SUNY Upstate geriatrician: drug requires further studies
By Steve Yablonski
‘The FDA approved the drug even though its outside panel of experts said there wasn’t enough evidence to show the medication slowed the disease’s progression.’
Geriatrician Sharon Brangman, chairwoman of Upstate University Hospital’s Center of Excellence for Alzheimer’s Disease.
Q: Can you tell us about your background?
A: I am the chair of geriatrics and the director of Upstate University Hospital’s Center of Excellence for Alzheimer’s disease. Because of my work in geriatrics and the fact that Alzheimer’s disease and other dementias are a disease that are more prevalent as we get older, I have been doing a lot of work with Alzheimer’s disease.
Q: What is Alzheimer’s disease?
A: Alzheimer’s is a brain disease where the brain cells die and the neurons that help with memory no longer work. It destroys memory as well as other important mental functions. It changes the way people’s brains work in the sense of making decisions, how they physically function and get through the day. When people think of Alzheimer’s, they immediately think of a memory problem and that is a part of it. But it really is a generalized brain disease that begins to change everything about a person including their personality, their daily function.
Q: Can it be cured?
A: It is an incurable, progressive brain disease. It primarily affects people over 65.
Q: Is what is commonly referred to as a “senior moment” a red flag?
A: No, not necessarily. As we get older, there are changes in the ways our brains process various information. Memory loss is not a normal part of aging. But as we get older it may take a little longer to process information. If those senior moments begin to interfere with your daily function, that’s when we get concerned that it could be something more. I usually encourage anyone who is concerned about their memory to get an evaluation, because not everything is dementia.
Q: How is it treated?
A: Right now we do not have any medication that cures or reverses the process that triggers Alzheimer’s. The current medications, which have been out for more than 20 years, manage some of the symptoms but they don’t change the underlying disease. As of this time, Alzheimer’s disease does not have a cure. It gets worse with time.
Q: The FDA recently approved Aduhelm, the first new drug to treat the disease in many years. What is it and how does it work?
A: It is an antibody, which is a drug that targets amyloid plaque, a type of protein, in people’s brains. There is an association between this abnormal build up of this protein in the brain and the development of Alzheimer’s disease. That doesn’t mean that everyone who has amyloid in their brain will get Alzheimer’s. And, it also means that if you don’t have amyloid you can’t get Alzheimer’s. The question is, does removing this amyloid help the brain maintain or regain any of its functions? This new drug removes the amyloid very efficiently. But the question is, after the amyloid is gone, is it helping? Is it making the symptoms of Alzheimer’s disease better, is it keeping someone stable? Is it restoring any of their brain functions? Those are the questions that we don’t have an answer for right now. It requires more data.
Q: Are there side effects?
A: Yes, it increases small bleeds in the brain and swelling in the brain. You have to take brain scans at a regular basis when you are on this medication. According to some trials, these side effects do go away after a period of time. Some people do get more severe symptoms than others; that’s based on some other factors that we have to take into consideration at the time of treatment. So, right now there are a lot of questions about who should actually take this medication. And, does this medication really help?
Q: You are concerned the drug might not work as well as advertised?
A: With a disease as devastating as Alzheimer’s, you can imagine, people are clamoring to try this drug. They are so desperate for anything that they hope will fight this disease.
Q: So, would you feel comfortable prescribing it to someone who requested it?
A: We’re working very hard to figure out what is best for our patients. We’ll gather all the information that we can so that they can make a good choice.
Q: More research is required?
A: The FDA approved the drug even though its outside panel of experts said there wasn’t enough evidence to show the medication slowed the disease’s progression. Three scientists resigned from the committee in protest after the approval, because the evidence wasn’t there. They thought the drug needed more study.
Q: How long would that study have to be?
A: That is a good question. They approved this drug under “accelerated approval” which means the drug has a chance of helping people, but the company has to do more research to see if it really helps. So they have up to nine more years to come up with studies to see if the drug helps. So, yes, this is still a research question. There are other companies that have similar molecules and they have on-going studies that are happening right now. It’s possible that we will have more information from those studies. Right now, we just don’t have enough information about Aduhelm to know how well it works.
Q: Why does it cost so much?
A: We are waiting to hear from Medicare to see what they are going to cover. The drug itself is expensive; the scans that you have to get are expensive. This drug is given by an IV infusion, that means you have a co-pay for every time you go to the infusion center, usually once a month. You would have a co-pay every time you get a brain scan. And, to determine whether you have a buildup of amyloid, you have to have a special brain scan.
Q: Is the decision up to the patient?
A: So we have a lot of things to sort out so we can help our patients make a good decision. It’s been approved by the FDA. Some people want it, they are willing to take that risk; a drug that may have side effects but may help them. So what I’m trying to do is figure out as much information as possible so I can help patients make the best decisions for their care.
The drug is legal and it’s available and I just want to make sure that we are informing people so that they understand it.
There are some people who have a higher chance of getting those brain bleeds or brain swelling. But they may also have a higher chance of getting a benefit. So we have to be able to help people weigh their risks. Everyone has the right to weigh their risk. It’s not my job to say absolutely not if the drug is legal. My job is to make sure people have got the information they need so they can make the best decision.
Q: How busy does this make your office?
A: Our office is very busy; has been for a number of years. Since this announcement we’ve had numerous patients and families calling asking if they are eligible to take this medication. So an already busy clinical office has gotten even busier.