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Showing posts with label high blood pressure. Show all posts
Showing posts with label high blood pressure. Show all posts
Sunday, February 17, 2019
February: American Heart Month - how much do we REALLY know, of the heart?
It has been nearly a year since I last posted here. I have had an eventful year, including employment changes, more conferences and illnesses sundry. I have been itching to get back on this blog
Very recently, I got tested for cholesterol, and received mixed, yet mostly bad news. Yes, yes, medical privacy, blah blah, but I am a scientist and don't fear sharing a bit about myself. So, my triglyceride count (119, 879 mg/dL max) appears to be within control, as is my LDL (134, 159mg/dL max), but my HDL came in at a disappointing 35 (40 min, 60mg/dL preferred).
Turns out, this is quite the cause for alarm! For men, HDL is not supposed to fall below 40mg/dL. So, I started doing research. And maybe I watch too many sci-fi movies and CSI shows (not CSI, but I am a sci-fi and true crime junkie), but what I found is quite disappointing.
First, the bias
Being in the medical devices industry can be quite irritating. On one end, we are part of an industry, that along with pharma and biotech oversells treatment benefits, disease cure rates, etc. Every week, one conference or the other has one SME or the other, spinning tales of how far we have come and how well we are doing. In context, cardiovascular surgeons and doctors tend to fight off the brain and nerve guys to be labeled the more effective rock stars.
It is perhaps absolute heresy then, to state that we actually know very little of what we work with. And by "we", I mean all of us - doctors, engineers, scientists, the whole shebang! Yes, we know more than we did, say, about 50 years ago, but there are still way too many unknowns. I have long lamented that many medical devices are not truly rooted in research and basic science. Formerly, my example used to be those "fancy drills" that root through your arteries trying to get rid of plaque (breaking and sending smaller bits into narrow vessels in the brain, necessitating an old-fashioned sink drain style filter). Along came renal denervation. Before DNA and genetics, a doctor or doctors, decided to cut off nerves around the kidney, and found that it dropped blood pressure. And then, some company took that, and with almost no scientific basis, turned that into a device solution. Medtronic, either due to naivety or an effort to drum up the hype, spent a billion odd dollars buying that company. People, especially with their own nerve-chop shops, like to pretend it was the design of the trial that screwed up renal denervation.
In reality, even if the trial was poorly designed, things still look bad. Blood Pressure Reduction has been a tricky problem for a while now. Medication developed through trials on Caucasians was found to be mostly useless when prescribed to African Americans. The Obama administration, seized on this genre of problems and tried to refocus the NIH and other agencies towards research on the basis of race. (As a side note, most devices are also built for adult males, making them unsuitable for women).
More recently though, Iceland became the subject of research that helped isolate genes responsible for High Blood Pressure. Since the population of Iceland is nearly uniform, and because of cultural proclivities, the islanders were typed and the gene was isolated. Now the race is on to build drugs to reduce blood pressure, based on genetics. In the face of that, a crude nerve-searing gizmo falls flat.
The message?
When fundamental science is applied as the basis for developing drugs or devices, things go far better. However, most of the time, this is not the case. Now, let us turn to my misadventures with cholesterol.
What we know and don't know about cholesterol:
[This is part of ongoing research. So, I will either create new posts or append references here later, but all of the below stated facts are easily found through basic search engine research.]
1. Cholesterol medications such as statins, mostly lower LDL, but do not help with increasing HDL much.
2. When HDL is increased naturally, it helps fight off cardiovascular conditions and death due to them consequentially. Apparently, when HDL is increased via medication, the cardiovascular benefits are not realized! The reason is unknown!!
3. To make things worse, there is only a correlation, unexplained scientifically between HDL levels and cardiovascular disease (yes, high HDL can reduce LDL and thus eventual atherosclerosis, but the other benefits are not clearly related).
4. Research indicates low HDL levels can be correlated to other disease conditions such as cancer! Again, the relationship is not very clear.
5. Many of us have been exposed to the simplified explanations of LDL and HDL as two molecules. In fact there are variants of HDL, and the effects of the individual molecules is not known.
6. Certain foods and exercise are listed as the mechanisms to increase HDL in a way that allows for resilience towards heart diseases. Nutritional science has huge gaps, and it is unclear how many of these recommendations are actually reliable.
7. The FDA doesn't really know how accurate the in-home cholesterol tests are. The only known comparisons to hospital tests are those done by the vendors themselves. Follow up lab tests can happen at intervals of six months or longer, unless you are asked to take medication, in which case the follow up would be six weeks - but this is all typically geared towards those with high LDL levels. An appropriate alternate could be in-home tests, but if no one is particularly able to verify the accuracy claims of the test vendors, how could one use this as a metric? This is not a pedometer we are talking about. This is cholesterol.
Conclusion
There is perhaps much more that is unknown about cholesterol and HDL, and that is very scary. I think there are two important things to consider:
1. Collectively, we have drifted away from considering fundamental scientific research. Pharma is better than devices, but one it is not enough. Secondly, while the endpoint of research has to be the development of a drug, device, combination or a diagnostic, etc., it is important to promote fundamental research. Organizations such as IBM once did this really well in the high technology industry. This is really missing in the medicine universe.
2. Uncovering knowledge will not be enough. We live in some truly perplexing times, ranging from an anti-science US Government, to people who deny vaccines and face no consequences for exercising such antithetical beliefs, putting children and society at large, in grave danger, unnecessarily.
May we use commemorations such as the Heart Health Month, to create awareness, not just of disease conditions, but on how little we actually know of them!
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Sunday, May 24, 2009
Got a patent for drug combinations on cardiovascular disease? How about "proving" everyone needs the drug...
[Click on the following for Link to External Article]
Click here for the Medscape Article
The actual study is here:
Click Here
The Premise
Call me a skeptic, call me rude, call me anything you want..But having seen and known too much about conflicts of interest and bias in clinical trials and studies, I become suspicious, especially so when I see small studies and more importantly "meta analyses" make broad stroke recommendations.
Thus when I saw a study that said "Feed all old people anti-hypertensives", I became wary. Alright, the title of the article was a little less crude, I admit. But, nevertheless, it did not please me. Let's examine some quick facts:
Some notes on the study
1. The study examined data from 147 clinical trials conducted over 40 years.
2. The study concluded that all 5 major classes of anti-hypertensives seemed to reduce the risk of cardiovascular events regardless of the patients' history with respect to either prior cardiovascular events/risk or hypertension.
3. How much of a reduction in pressure where they looking for? A 10mm mercury reduction in systolic and 5mm in diastolic pressures.
Results, Conclusions and Recommendations
The study results do look good, just like they do in meta-analyses. After all, you are not directly studying something, just looking for what you would like to see.
People with hypertension are definitely on their path to cardiovascular events. The real difference comes from a combination of hypertension and other factors.
What is the real gripe?
The studies should have focused on reducing hypertension, and consequentially, cardiovascular events in patient populations pre-disposed to hypertensive and cardiac disease. If the 22% reduction in coronary artery disease and 44% reduction in stroke was comparable in both groups, how can we actually assume that patients who we consider not pre-disposed to CV/hypertensive were indeed not actually pre-disposed to the disease?
Well, there can only be one of three answers:
1. That, in these studies, at a broad level, folks who were not considered "at risk" were indeed at risk, and 147 studies were designed poorly. Okay, that is an extreme position to take, but at least some of the studies should be wrong, right?
If not, shouldn't you see a comparable decrease in CV events in patients/controls considered not "at risk"? Well, let's consider the other possibilities.
2. It is quite possible that the controls who were not considered "at risk" would have not really taken good care of their health. They let their life styles slip and as a result, ended up with cardiovascular disease.
3. Since at least some of these studies were treating patients for other factors, such as cholesterol, it is possible that they had a role to play in disease mitigation and the 22% and the 41% might have been influenced by the study population being treated for other conditions - see the problem with "large" and "comprehensive" meta analysis?
The Conclusion and a Side Note
Anyway, at the end of it all, when I came down to the article's end, I found out that the scientists involved in the study, who recommended (albeit with warnings on the fringe about drug combinations) that every "older adult" should be asked to take anti-hypertensive medicine actually own patents on drug combinations...
You can conclude the rest for yourself, but I am no Doctor, and still, I am going to try the "lifestyle change". I really think the idea of popping anti-hypertensives after I reach my "older adult" stage sucks. If that is what I am looking for, I might as well harm my already poor lifestyle a tad bit more...
Other problems?
1. What about people prone to low blood pressure? What if some company thinks it is a great idea to make blood pressure medicines to be a "dietary supplement" and someone prone to lower blood pressure accidentally takes it?
2. Hmm, have you thought about side effects of blood pressure meds before telling the world to take 'em?
A side note: Was aspirin also gold-standardized in a similar manner for all "older adults"?
You know, with the new wave of recommendations on hypertension coming from the old world on the basis of some extremely strong metanalysis, I got to wondering if Aspirin was also pushed on us in a similar manner. Remember when Bayer wanted to call Aspirin a "Dietary Supplement"?
Well, it does not appear to be as flimsy as the anti-hypertensives:
http://circ.ahajournals.org/cgi/content/full/96/8/2751
The AHA seems to have done a fair job, with 22,071 male physicians testing themselves with aspirin as an alternate therapy, resulting in a 44% reduction in MI. Of course, given they are physicians and knew about hypertension, hyperlipidimia (fancy for High Cholesterol) and smoking, maybe, just maybe some of them made "lifestyle changes".
Somewhat comforting, eh?
Click here for the Medscape Article
The actual study is here:
Click Here
The Premise
Call me a skeptic, call me rude, call me anything you want..But having seen and known too much about conflicts of interest and bias in clinical trials and studies, I become suspicious, especially so when I see small studies and more importantly "meta analyses" make broad stroke recommendations.
Thus when I saw a study that said "Feed all old people anti-hypertensives", I became wary. Alright, the title of the article was a little less crude, I admit. But, nevertheless, it did not please me. Let's examine some quick facts:
Some notes on the study
1. The study examined data from 147 clinical trials conducted over 40 years.
2. The study concluded that all 5 major classes of anti-hypertensives seemed to reduce the risk of cardiovascular events regardless of the patients' history with respect to either prior cardiovascular events/risk or hypertension.
3. How much of a reduction in pressure where they looking for? A 10mm mercury reduction in systolic and 5mm in diastolic pressures.
Results, Conclusions and Recommendations
The study results do look good, just like they do in meta-analyses. After all, you are not directly studying something, just looking for what you would like to see.
People with hypertension are definitely on their path to cardiovascular events. The real difference comes from a combination of hypertension and other factors.
What is the real gripe?
The studies should have focused on reducing hypertension, and consequentially, cardiovascular events in patient populations pre-disposed to hypertensive and cardiac disease. If the 22% reduction in coronary artery disease and 44% reduction in stroke was comparable in both groups, how can we actually assume that patients who we consider not pre-disposed to CV/hypertensive were indeed not actually pre-disposed to the disease?
Well, there can only be one of three answers:
1. That, in these studies, at a broad level, folks who were not considered "at risk" were indeed at risk, and 147 studies were designed poorly. Okay, that is an extreme position to take, but at least some of the studies should be wrong, right?
If not, shouldn't you see a comparable decrease in CV events in patients/controls considered not "at risk"? Well, let's consider the other possibilities.
2. It is quite possible that the controls who were not considered "at risk" would have not really taken good care of their health. They let their life styles slip and as a result, ended up with cardiovascular disease.
3. Since at least some of these studies were treating patients for other factors, such as cholesterol, it is possible that they had a role to play in disease mitigation and the 22% and the 41% might have been influenced by the study population being treated for other conditions - see the problem with "large" and "comprehensive" meta analysis?
The Conclusion and a Side Note
Anyway, at the end of it all, when I came down to the article's end, I found out that the scientists involved in the study, who recommended (albeit with warnings on the fringe about drug combinations) that every "older adult" should be asked to take anti-hypertensive medicine actually own patents on drug combinations...
You can conclude the rest for yourself, but I am no Doctor, and still, I am going to try the "lifestyle change". I really think the idea of popping anti-hypertensives after I reach my "older adult" stage sucks. If that is what I am looking for, I might as well harm my already poor lifestyle a tad bit more...
Other problems?
1. What about people prone to low blood pressure? What if some company thinks it is a great idea to make blood pressure medicines to be a "dietary supplement" and someone prone to lower blood pressure accidentally takes it?
2. Hmm, have you thought about side effects of blood pressure meds before telling the world to take 'em?
A side note: Was aspirin also gold-standardized in a similar manner for all "older adults"?
You know, with the new wave of recommendations on hypertension coming from the old world on the basis of some extremely strong metanalysis, I got to wondering if Aspirin was also pushed on us in a similar manner. Remember when Bayer wanted to call Aspirin a "Dietary Supplement"?
Well, it does not appear to be as flimsy as the anti-hypertensives:
http://circ.ahajournals.org/cgi/content/full/96/8/2751
The AHA seems to have done a fair job, with 22,071 male physicians testing themselves with aspirin as an alternate therapy, resulting in a 44% reduction in MI. Of course, given they are physicians and knew about hypertension, hyperlipidimia (fancy for High Cholesterol) and smoking, maybe, just maybe some of them made "lifestyle changes".
Somewhat comforting, eh?
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