Dr. Domenic Sica: Yes. One of the things a good hypertension specialist does is, if a drug is not working you don?t have them take the drug. If someone is on six drugs and they come to see me, the first thing I tell them is I?m going to make you better somehow. I?m going to start off by taking away medicine. You tell me if your blood pressure goes up further without a specific medicine. If you systematically pull back a medication or a second or third medication you may discover that one or the other of them was in fact doing something. If it is, then it?s worthwhile to continue that medication. People who are resistant on four or more drugs, it?s not a bad strategy to back off on medicines. Have one or another drug call itself useful, usually I take away the medicine that cost the most. The costing of medicines now for the resistant hypertension probably for those on six or seven drug therapies is about $150.00 to $450.00 per month. It?s a good idea to know what the old drugs do and what is on the $4.00 plan at any of several pharmacy chains. This is a good way for cost savings for the patient.
You are still going back to the Doctor to get your battery replaced at a cost?
Dr. Domenic Sica: It will be covered; there will be a coding that will be provided. There is already movement for reimbursement. Once approved it will not be an issue with the battery change, it will be an issue to get approval for implantation in the first place. If the insurance companies approve it, then the battery change is small dollars compared to everything else. I think what will happen, there will be carefully selected patients who will be picked out from the larger body of resistant hypertensives, as being good candidates once the device is available for widespread use. There will be extensive training for the doctors who are implanting the device.
What would be the criteria that would make a good candidate besides being drug resistant?
Dr. Domenic Sica: Drug resistant patients who have had excessive medication related side effects, and you?re limited to how many drugs you can use. Various forms of what we call endocrine disease although not carefully studied in patients with chronic kidney disease, it?s likely to have a reasonable impact on the blood pressure in patients with chronic kidney disease. It?s not formally been studied in dialysis patients. They too would likely be good candidates for the device. If someone?s on six drug therapies and the device can get you three drug therapies, along with getting your hypertension under control, that?s a huge gain. But, to get people completely off medications would be unusual since their blood pressure is so high from the start.
What?s in the future for this device, you stated that the device was probably two years out before approval, normally by that time there is something better on the horizon?
Dr. Domenic Sica: The other treatment consideration for resistant hypertension is a procedure called renal nerve ablation, which is being actively studied in clinical trials. It is a procedure that does not require implantation; rather, it?s done in the course of an angiogram. The angiogram is such that a catheter is introduced into the femoral area, which is located in the groin area. The catheter is threaded upstream in the aorta until the takeoff of the renal artery is identified and it then is maneuvered into one or the other of the renal arteries. The outside wall of the renal artery is embedded with nerves that can be ablated by radiofrequency waves coming from the catheter. Typically, both kidneys undergo this procedure. The blood pressure drop the follows from this procedure can be significant; however, it is not of a significant enough magnitude for medication therapy to be stopped. The catheter needed for this procedure is available on the open market in Europe and is undergoing clinical trials in the United States.
Can you tell me how people get involved in clinical trials?
Dr. Domenic Sica: Clinical trials are critical and as you are aware of. If you?re careful in where you look most major medical centers have a clinical trial division. Their websites would have ways by which you can recruit or be recruited as a subject into a clinical trial. There are a number of clinical trial opportunities that are available for a pay for service type basis with freestanding clinical trial units that are there. If you look in a newspaper, there are generally advertisements for clinical trials that are there. If your doctor is in a medical center and you have a specific disease and you want to know what?s out there in a clinical trial. Conferring with your doctor would be useful and your doctor will allow you the opportunity to be funneled to the correct location. For example, if I?m seeing someone who has breast cancer and they also have high blood pressure and, I know their breast cancer status. If I know there?s a new clinical trial kicking off, then I would refer a patient to the investigator involved in that clinical trial. Most universities are very active in recruiting and are no longer uncomfortable with the fact that they do clinical trials. There?s a lot of time spent almost apologizing for the fact that patients feel like guinea pigs. Clinical trial care may actually be better than routine clinical care because there?s attention to every detail, often times there?s a modest financial incentive for the patient, major elements of their care are provided free of charge as part of the trial. Many times drugs are provided free of charge also. The only thing you have to do is that ultimately, you are doing something that will probably help you and others with the same disease. What?s changing is that there?s pride now in it. Doctor?s don?t have to worry about I?m offending a patient by asking them. At all times patients should be aware of what goes on in medical trials. The patient should make an informed decision. The doctor should never make a decision to talk to the patient or not because they feel like the patient would be disinclined.
I?ve talked to several patients who have been a part of clinical trials and some of them have told me they wouldn?t be here today if it wasn?t for that clinical trial. What they needed wasn?t available yet. So they could wait for the FDA to approve something and die or they could possibly go into some type of trial and live.
Dr. Domenic Sica: A lot of that has to do with oncology or chemotherapy drugs. But I can?t emphasis too much the fact that the care provided to the patient during the clinical trial and the follow up is different than what is done normally. You are being studied, people are trying to gather as accurate information as they can, and so they can collate it, analyze, and get it to other patients as soon as possible. We don?t do the same kind of collation with available drugs. You may be on an available drug, you may get great care but you may not be getting the same intensity or complexity of care in monitoring. You are all of the sudden learning things about your disease, which is now under a microscope even more so than usual when you?re in a clinical trial. There?s a feeling of bonding with your doctor and research coordinator in a different way. There?s always bonding that occurs between a doctor and a patient but in clinical trials there?s something just a little bit different in that bonding. Family?s often times get more involved in the care. A lot of patients also become advocates in their own right. The more people that speak up the less the fear factor. Fear, often times is cultural in nature. There?s a bias against trials for some patient groups. People simply don?t understand. The consent forms for these trials are at a sixth to seventh grade level. The most intelligent people even can get confused with consent forms, just taking the time to explain and educate them, even if they decide not to, means you?ve taken that next step to help them understand disease in general. I think the best recruiter involved is a previous clinical trial patient who did well, who was brought through the difficulties of their illness and speak up knowledgably. The best part of their experience may not have been the drug, but their participation. Their information is going to help someone else.
With diseases which are not life threatening, there?s less of a priority for these trails. For example, a blood pressure trial. There are different motivations as to why they come in. Some people just love the environment, they love the research coordinator, they like the frequency of which blood pressure is measured. A lot of them have the twenty-four hour monitoring done, there?s a lot of data retrieval for them. When you take a drug and you see if your blood pressure changes or not, you find it comforting to know what drug it is that worked in the clinical trial hoping you may be able to get that same drug when the trial finishes.
How easy is it to get involved in clinical trials, what are the steps you must take?
Dr. Domenic Sica: For example, we have a clinical trial website here at VCU. You could see what?s available; there are preliminary screening forms there. There are call back phone numbers. It?s quite simple to understand what the trial is, what the expectations of your involvement are and it can be done from your home.
Are there any drawbacks in participation?
Dr. Domenic Sica: No. People many have a philosophical drawback; I don?t want to be experimented on. That?s a personal decision made on the part of the patient. There?s never harm in learning, if you learn and you?re not forced into a particular activity.
I recently interviewed a woman in Portland who had melanoma that was told four years ago, she had six months to live. She is probably on her fifth or sixth clinical trial. Her thought was if I go on one trial that doesn?t work, I can try another trial. They can move you around to try what?s on the cutting edge, correct?
Dr. Domenic Sica: Yes. Being financially responsible is an important part of clinical trials. Many patients can?t even afford the chemo therapy. These are not $100.00 drugs; they are tens of thousands of dollars for cycles. If your insurance company was not reimbursing you, it?s out of pocket. Sometimes, a clinical trial can save your life savings and not burden your family. You also may receive a drug that?s not even on the market yet.
FOR MORE INFORMATION, PLEASE CONTACT:
Domenic A. Sica, M.D.
Virginia Commonwealth University Health System