Is there any risk to it?
Dr. Brown: So, there is always a risk to every procedure. Every invasive procedure carries some risk, but the risks are low. We like to deal with risks that are below 1% or less than 100. There is always a risk of causing some burn in the muscle that causes some stenosis; that it may wind up needing to have a balloon or stent done to it. Every time we stick a needle in somebody, there is risk of infection, bleeding, and blood clots forming. However, these are all the common risks of every procedure we do and even the surgeries we do, but this is essentially noninvasive surgery. So it is a needle stick, minimally invasive without having to cut you open.
Can you tell me about the 13 you have done?
Dr. Brown: This is not only a randomized trial, but it is a double-blind randomized trial. What does that mean? It means the patient does not know what treatment they get. It also means that we as physicians do not know what treatment they get. The intent of that is a very successful study done outside the United States to kick this off, but our FDA is always concerned about, how that really comes out and are people subject to sort of Madison Avenue advertising and marketing and can we convince somebody of the placebo effect. So, we have to eliminate that almost completely to know that that is really not what is going on. By doing that and not having anybody we go to the extent to put earphones on the patient, play music, and put blindfolds on them; so they cannot have any idea. We simulate the exact procedure. We simulate the burns and then we even give them a quiz that the FDA approved. It says, “Did you or did you not get real treatment?” So, we really do not want them to know. So, we do not know those results. We know the results from the previous studies. We know what happened before and they were dramatic. Blood pressures came down from an average of 160 to 128, 32 mmHg drop in your systolic blood pressure and that lasted and persisted now out to 3 years. It was 1 month, then 6 months, then a year. We have got the 2-year and 3-year results.
Is that the phase II clinical trial or?
Dr. Brown: I think this is still phase I clinical trial, but there was a first trial and a second trial. Now we have the trial being done in the U.S. and Europe that everybody is looking to see is this going to be the same result.
Can you see this procedure treating people with just slightly higher blood pressure to keep them off medication?
Dr. Brown: I do not know and that is really the reason we are doing the trial and the reason trials are so important to medicine; so important in this country. The first thing is we take the worst and most difficult patients; the patients who need it the most, who have been unable to be controlled on 3 or more medicines. These patients are on 3, 4, 5 medicines. They have already been pushed to maximum dose and their blood pressure still is not controlled and that is the cohort or the group that the FDA picked out for us to do. They said, look, you get the sickest of the sick. You make it work there and you do not screw up, we will give you another shot at it. Then we will look at the intermediate group and then we will look at the lower risk group, but depends on how it comes out and we need to make sure there are no side effects and no complications to do that.
When you say that people who cannot control their blood pressure with medication or anything, they automatically assume the worst; they do not exercise, eat right, or they are not treating their bodies well. Is this genetic when it gets to that point?
Dr. Brown: No. There is an element of genetics certainly in all of this, but there is no question. It is a classic case of the better you take care of yourself, the better you are going to do, even if you are a person who is going to be normal or even if you are a person who is going to be hypertensive. Better eating, better exercise, weight drifting down, control of salt, and control of sodium intake, all those things have a significant role. Now, your point I think is very accurate that there are a lot of people who even when they do that and we get them on the right medicines, still have high blood pressure. It has been this evolution of genetics and those people do not have any way to go; so that is how we get there.
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