While I don't plan on writing daily updates until August, I figure that I want to get in the habit of writing thoughts down when they occur. Over the weekend I met a lady who is 73. She has severe osteoporosis but because she has bad side effects to oral bisphosphonates, she does not want to try even an intravenous bisphosphonate. Instead, she was trying an unproven combination of Evista and Calcitonin nasal spray. This lady is not one of my patients. She told me she has lots of medical people in her family and on their advice, she decided that the risks of using an IV bisphosphonate like Boniva or Reclast was not worth the benefits. It's not clear to me what she perceived the risks and benefits to be or how she came to that conclusion. She may be right, she may not be but it did make me reflect that how people make medical decisions is really really interesting.
The way physicians make decisions is they use studies to try to quantify the risks and benefits and if the benefits outweight the risks (and don't cost too much), then it's the right decision to try the treatment. If the risks outweigh the benefits, then it isn't. There isn't a lot of emotion in the decision. In the situation that there is no evidence, or poor evidence, then the situation is tricky.
The way I see it, which is limited I'm sure, patients make decisions quite a different way. Most patients don't have access to the studies, or have trouble making sense of the medical literature. There are several categories of decision making process that I see patients go through: some try to weigh risks and benefits as interpreted by their physician, some decide based on what they fear more (fracture or side effects), some by gut feeling, some by cost, some by what somebody famous says or by what family says. In other words, patients look to a different source of authority for decision making information.
What's challenging for the physician (and patient) is to bridge this gap. As I write about different issues, I hope to give the information needed to help any person make an educated decision regardless of decision making style. We'll see how it goes!
Monday, June 29, 2009
Saturday, June 27, 2009
What is Axona?
I hope to write some critiques of treatments that are in advertisements to give some perspective to claims. So one thing that I get is called Clinical Geriatrics. It's a subscription I get from my membership in the American Geriatric Society. This last issue there was a supplement (i.e. advertisement) about a new nutritional supplement called Axona that will help patients with Alzheimers.
So what is Axona?
Axona is essentially a variety of fatty acids (fats) that get metabolized to ketones. So what? Well the brain can use ketones as well as glucose in helping us think. Since the brain that has Alzheimer's has trouble using glucose, maybe supplying some ketones will provide more energy to the brain.
So does Axona work?
That depends on what the goals are. If the goal of an Alzheimer's patient or family is to keep the patient functional, out of a nursing home, engaged in hobbies and relationships then the answer is unknown. If the goal is to see a miniscule improvement on a research cognitive scale (ADAS-cog), then the answer is, according to the manufacturer's 1 study, yes. At 45 days there was a 1.91 point difference between the two groups (out of 70 points). By 90 days this improvement disappeared.
Conclusion
Axona may have an effect on cognition that a researcher may be able to detect, but I am doubtful that any family member or patient would notice. In any case, the benefit disappears by 90 days according to the manufacturer's own data. And according to the data, for every 8-9 patients treated, 1 will get a side effect (like diarrhea).
My conclusion is that this nutritional supplement is interesting, but not worth trying yet.
edit: As one comment points out, this medication/food supplement is a single triglyceride (>95%). But I think it is made from a variety of oils (palm oil and others) due to the warning on label regarding food allergies.
Edit (6/12/2011)
I realized that this is my most viewed post on my blog and I would like to update it a little. There are several things I would like to see studied/researched about any specific intervention for dementia before I get too excited about it: The intervention has to
1. Show a difference between placebo and treatment in long term studies (i.e. more than 6 months)
2. It has to show an effect in both research scales and clinically oriented outcomes
3. Clinical significance (as opposed to statistical significance) has to be defined separately from the study
4. The study has to be large enough to define subgroups (i.e. those who achieve the threshold of clinically significant change/improvement)
5. A Number Needed to Treat needs to be able to be calculated
6. Ideally a way to tell if the treatment is working or not working would be researched along with effectiveness
7. Discontinuation studies need to be done that are not simply open label studies in order to allow people to feel comfortable stopping a med that will likely not benefit the majority of subjects.
These seven criteria will allow a patient/physician to know what a medication is supposed to achieve and whether it is clinically meaningful, what percentage of people actually achieve it, when it is not working so it can be stopped and the risk involved of stopping it.
To be fair to Axona, no medication/treatment meets these criteria so it is hard for me to get excited about any pharmacological intervention. I'm not a fan of starting a medication without knowing if it is working, whether it is doing anything clinically meaningful, how likely someone is to get benefit, when to stop it and risks involved.
So what is Axona?
Axona is essentially a variety of fatty acids (fats) that get metabolized to ketones. So what? Well the brain can use ketones as well as glucose in helping us think. Since the brain that has Alzheimer's has trouble using glucose, maybe supplying some ketones will provide more energy to the brain.
So does Axona work?
That depends on what the goals are. If the goal of an Alzheimer's patient or family is to keep the patient functional, out of a nursing home, engaged in hobbies and relationships then the answer is unknown. If the goal is to see a miniscule improvement on a research cognitive scale (ADAS-cog), then the answer is, according to the manufacturer's 1 study, yes. At 45 days there was a 1.91 point difference between the two groups (out of 70 points). By 90 days this improvement disappeared.
Conclusion
Axona may have an effect on cognition that a researcher may be able to detect, but I am doubtful that any family member or patient would notice. In any case, the benefit disappears by 90 days according to the manufacturer's own data. And according to the data, for every 8-9 patients treated, 1 will get a side effect (like diarrhea).
My conclusion is that this nutritional supplement is interesting, but not worth trying yet.
edit: As one comment points out, this medication/food supplement is a single triglyceride (>95%). But I think it is made from a variety of oils (palm oil and others) due to the warning on label regarding food allergies.
Edit (6/12/2011)
I realized that this is my most viewed post on my blog and I would like to update it a little. There are several things I would like to see studied/researched about any specific intervention for dementia before I get too excited about it: The intervention has to
1. Show a difference between placebo and treatment in long term studies (i.e. more than 6 months)
2. It has to show an effect in both research scales and clinically oriented outcomes
3. Clinical significance (as opposed to statistical significance) has to be defined separately from the study
4. The study has to be large enough to define subgroups (i.e. those who achieve the threshold of clinically significant change/improvement)
5. A Number Needed to Treat needs to be able to be calculated
6. Ideally a way to tell if the treatment is working or not working would be researched along with effectiveness
7. Discontinuation studies need to be done that are not simply open label studies in order to allow people to feel comfortable stopping a med that will likely not benefit the majority of subjects.
These seven criteria will allow a patient/physician to know what a medication is supposed to achieve and whether it is clinically meaningful, what percentage of people actually achieve it, when it is not working so it can be stopped and the risk involved of stopping it.
To be fair to Axona, no medication/treatment meets these criteria so it is hard for me to get excited about any pharmacological intervention. I'm not a fan of starting a medication without knowing if it is working, whether it is doing anything clinically meaningful, how likely someone is to get benefit, when to stop it and risks involved.
Friday, June 26, 2009
Introduction
Blog entry #1
Geriatric Issues: A blog of questions and answers
After being a practicing physician for four years, I decided to go back to training to do a Geriatric Fellowship. I'm finishing my fellowship on Tuesday and after that I'm joining the University of Pennsylvania as a faculty in Geriatrics.
Geriatric Issues: A blog of questions and answers
After being a practicing physician for four years, I decided to go back to training to do a Geriatric Fellowship. I'm finishing my fellowship on Tuesday and after that I'm joining the University of Pennsylvania as a faculty in Geriatrics.
Geriatrics is something that has been on my heart since before starting medical school. I love the interaction with families and patients. Geriatrics is a field of change and transitions and one thing I find rewarding is helping patients and their families anticipate, adjust, and succeed in the transitions of getting older. In order to do this, one thing I have found myself doing very frequently is having family meetings, but the problem is that the more patients I get, the more family meetings I need to do and I end up having difficulty trying to communicate everything that I want to to patients and their families.
In many ways, I find that geriatrics is a lot like pediatrics-a lot of the transitions are predictable and if information can be given out in time, patients and families can plan for the future instead of waiting for crises moments like a hospitalization or a hip fracture. One of the purposes of this blog is to provide a forum to distribute good, accurate anticipatory guidance to patients and families to allow everyone access to the medical knowledge needed to make good decisions and to plan. The goal of this blog is to make sound medical information fully accessible to patients and their families to allow them to become as informed as a physician. In this day and age of Internet and the world wide web, I believe fully that nothing should stand between patients and medical information.
My second purpose behind this blog is to allow patients and families to ask me questions to challenge me. I find that patients often ask the best medical questions (usually something that begins with "why") and it pushes me to learn more, read, and be much more precise in my medical knowledge and practice.
I haven't done a blog like this before so this will be a work in progress. The format will be fairly straight forward-I will post entries and will come up with future topics from comments, emails, and things I'm learning from my practice. While there are many web sites to serve as resources on the Internet, I hope this blog takes on the flavor having geriatrician in your own family. I really hope to make this blog and my answers very interactive, personal and relevant to you. So, please feel free to ask questions and I hope you enjoy my blog!
About me:
I started my medical career at the University of Michigan where I received my B.S. in Biomedical Sciences in 1997. In 2000 I received my M.D. from the University of Michigan as well. From 2000-2003 I went to MacNeal Family Practice Residency Program-University of Chicago in Berwyn, IL and from 2004-2008 I worked as a solo practice physician in Shickshinny, PA. In July of 2008, I started my Geriatric Fellowship at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson. Starting August 1, 2009, I'll be on faculty at the University of Pennsylvania.
In many ways, I find that geriatrics is a lot like pediatrics-a lot of the transitions are predictable and if information can be given out in time, patients and families can plan for the future instead of waiting for crises moments like a hospitalization or a hip fracture. One of the purposes of this blog is to provide a forum to distribute good, accurate anticipatory guidance to patients and families to allow everyone access to the medical knowledge needed to make good decisions and to plan. The goal of this blog is to make sound medical information fully accessible to patients and their families to allow them to become as informed as a physician. In this day and age of Internet and the world wide web, I believe fully that nothing should stand between patients and medical information.
My second purpose behind this blog is to allow patients and families to ask me questions to challenge me. I find that patients often ask the best medical questions (usually something that begins with "why") and it pushes me to learn more, read, and be much more precise in my medical knowledge and practice.
I haven't done a blog like this before so this will be a work in progress. The format will be fairly straight forward-I will post entries and will come up with future topics from comments, emails, and things I'm learning from my practice. While there are many web sites to serve as resources on the Internet, I hope this blog takes on the flavor having geriatrician in your own family. I really hope to make this blog and my answers very interactive, personal and relevant to you. So, please feel free to ask questions and I hope you enjoy my blog!
About me:
I started my medical career at the University of Michigan where I received my B.S. in Biomedical Sciences in 1997. In 2000 I received my M.D. from the University of Michigan as well. From 2000-2003 I went to MacNeal Family Practice Residency Program-University of Chicago in Berwyn, IL and from 2004-2008 I worked as a solo practice physician in Shickshinny, PA. In July of 2008, I started my Geriatric Fellowship at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson. Starting August 1, 2009, I'll be on faculty at the University of Pennsylvania.
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