[ed note: Michael Jorrin is longtime medical writer who has been sharing his thoughts with our readers as “Doc Gumshoe” for several years (he’s not a doctor, I gave him the name). He generally covers medical and health news and sometimes health promotions and hype, but he rarely opines about investments or specific stocks. All of his past commentaries can be seen here]
I’m taking a rest from the cardiac arrhythmias stuff that I addressed but did not finish in my last piece. I’ll get back to that soon, but in the meantime I’m looking at a few current topics that have turned up on my desk via various routes. One, which Travis tossed over the transom, has to do with stem cells and whether a supplement called Vital Stem can foster the growth of stem cells and thus work as an antidote to aging.
Another “fountain of youth” supplement
The hook here is the stem cell connection. Stem cells are of great interest to the medical and scientific community. The Gumshoe cognoscenti have certainly heard a good deal about stem cells and their potential to repair all manner of damage in the human body. The potential is undeniable, but so far actual benefit is spotty at best. Every part of the body – bone, muscle, nerve, brain – is composed of mature cells which age and die, and also includes some stem cells which will mature to replace the cells that die off. These are the so-called “adult” stem cells. Embryonic stem cells, unlike adult stem cells, have the potential to mature into any and all human cells. Doubtless, you have heard of the controversy regarding the harvesting of embryonic stem cells. Human embryos harbor a small number of these stem cells, and harvesting the stem cells kills the embryo. Embryonic stem cells, termed pluripotent because of their capacity to grow into all types of cells, are not the kind of stem cells that Vital Stem purports to boost.
Stem cells undeniably have an intrinsic relationship with aging. Younger people have many more stem cells than older folks, and when cells die off – which, unfortunately, they do – older people have fewer stem cells hanging around to replace the lost cells. Cell damage and cell death takes place in all humans of any age (and in animals and plants too), but younger people have much more capacity to grow new cells. So it would be an excellent thing if there were an effective way to increase the supply of stem cells, which would not only shoo away the Grim Reaper, but keep us young and healthy.
The creator and promoter of Vital Stem is Randolph S. McClain, DO. He is a 2007 graduate of Western University of Health Sciences, in Pomona, CA, which teaches osteopathic medicine. Doctors of osteopathy are fully licensed physicians. The guiding principles of osteopathic medicine focus on the body as a whole, including the mind and the spirit, and a belief that the body is capable of self-regulation and self-healing.
Here’s the pitch from Live Cell Research, the manufacturer of Vital Stem:
“2016’s most talked-about innovation came yesterday when Dr. Rand McClain, the Los Angeles based ‘Doctor to the Stars,’ released his new technique for what some are calling the first true Body Repair formula.
“ And the reason everyone’s talking about it is because his method is based on technology that was actually banned by the U.S. government in 2001. However, Dr. McClain and his partners have discovered a loophole that allows them to go around the slow-moving government bureaucracy…and take their discovery straight to the American people.
“Dr. McClain wowed industry colleagues and members of the press with his new creation, which he revealed he’s already offering to his celebrity and pro-athlete clients with incredible results. In the video presentation – which may be taken down as early as this week – he details how some very big name athletes are achieving increased strength, healthier bodies, and even more energy.
“McClain feels the technique — which has been shown in clinical trials to actually alter specific cells in the human body — works best for people over 40, particularly those who may be experiencing excessive fatigue, weaker bodies, and even foggy thinking.”
The drill, according to McClain, is simple: you take one scoop of Vital Stem, stir it into a glass of water, drink it down first thing in the morning on an empty stomach, and, voila! – it’s like a magic fertilizer for stem cells, which will grow into new bone, muscle, skin, and even brain cells, fighting off aging and mental decline.
What might the miraculous ingredients in this supplement that keeps us young? Well, Vital Stem contains Vitamin D3, leucine, carnosine, green tea extract, and blueberry extract. Of these, leucine comes closest to having the effects that McClain is proclaiming. Leucine is an essential amino acid. We humans are not able to synthesize it, but it’s not very hard to find dietary sources, including soybeans, beef, peanuts, pork, salmon, wheat germ, almonds, chicken, eggs, pinto beans, chickpeas, lentils, oats, corn, milk …. The list goes on. And on. There appears to be evidence that leucine supplementation stimulates muscle growth in rats, but not in elderly humans, according to a 2008 paper in the American Journal of Clinical Nutrition. Whether the effect in rats has anything to do with boosting stem cells has not been, as they say, elucidated.
Another Vital Stem ingredient that may or may not deliver the advertised health benefits is carnosine, which is a sort of twin amino acid, consisting of β-analyl and L-histidine linked together. Like leucine, carnosine is reasonably abundant in protein-rich diets and perhaps a bit scarce particularly in vegan diets. Carnosine is an inhibitor of the formation of advanced glycation end products, which contribute to the aging process, and appear to be a factor in diabetes. There have been claims that carnosine supplementation actually delayed aging, in a cohort of elderly patients with established cataracts, and also that it stimulated the growth of stem cells in vitro. The claim that it delayed aging would be hard to substantiate, since that study only went on for six months. For such a study to have any weight, it would have had to run a good deal longer, and it would have had to compare the cohort that got the carnosine supplement with a matched cohort that did not get the supplement. And there would have had to be criteria: what is a normal rate of aging, and how do you measure it?
As for the other three ingredients: the benefits of Vitamin D3 are well known, the blueberry extract perhaps is intended to combat oxidative stress, and the green tea extract is no doubt included to attempt to recruit the many well-publicized benefits (bona fide or not) of green tea regarding cancer, heart disease, and other diseases, to the Vital Stem cause. Green tea extract, but not green tea itself, has been linked with liver damage. The American College of Gastroenterology has issued a warning about diet pills containing green tea extract. The specific components of green tea extract that can cause harm are catechins, which are antioxidants, but which can also affect our mitochondria. These are active in metabolizing food and converting it to energy. Excessive amounts of green tea extract can hamper the performance of mitochondria, leading to jaundice, hepatitis, and even liver failure.
It’s obvious that the campaign is, as usual, hugely overblown, with the familiar conspiracy theory themes that the U. S. Government is about to clamp down on Vital Stem because it threatens the medical establishment. Beyond that, the product itself is a bit of a swindle. It’s not quite in the same swindle category as the bottles of ayurvedic medicaments that consist almost entirely of fillers. But a bottle of Vital Stem will set you back about fifty bucks, and the main active ingredients – leucine and carnosine – are abundant in normal diets, and can be bought as supplements for a fraction of that figure.
So, on to another Thanksgiving Leftover.
Master Mineral Solution cures just about everything!
This one comes from the Genesis II Church of Health and Healing. I am just about 100% sure that no citizen of Gumshoe Nation would fall for this one, but just to elevate your eyebrows and elicit exclamations of baffled wonderment that anyone at all would fall for this, here’s the scuttlebutt. The genius behind this is a guy named (deceitfully) Jim Humble, who has written a number of books about his cure-all. The books are titled something like The Master Mineral Solution of the Third Millennium.
Humble’s miracle solution is purported to cure Lyme disease, MRSA (methicillin-resistant staph aureus), malaria, stomach and peritoneal cancer, hepatitis C, HIV, H1N1 flu, acne, the common cold, and maybe other diseases as well.
What is the Master Mineral Solution? The Genesis II Church of Health and Healing helpfully provides a formula, which starts off with 22.4% sodium chlorite. That’s chlorite, not chloride. Other ingredients include hydrochloric acid, citric acid, chlorine dioxide, calcium hypochlorite, dimethyl sulfoxide, diatomaceous earth, and zinc oxide. What this mixture produces is basically industrial strength bleach.
The label for this Master Mineral Solution recommends high oral doses of this stuff.
Side effects include vomiting, nausea, diarrhea, and severe dehydration.
The FDA issued a warning more than six years ago that this stuff could cause really serious harm to health, including life-threatening episodes of low blood pressure. Despite this warning, the Genesis II Church recently pronounced that the Master Mineral Solution will cure autism. And if the kids experience those symptoms, that’s evidence, says the Genesis II Church, that their magical elixir is working!
I wish to add here that the health benefits of bleach were being touted considerably before the Third Millennium. When my little sister came home from Girl Scout camp with a serious case of poison ivy, which she had acquired in inconvenient areas of her body while relieving herself in the woods, the mother of one of her friends recommended bleach, applied externally to the rash. Of course, it made the rash much worse, and my poor sister endured the consequences for weeks. I can just imagine what bleach would do taken internally. Not a nice thought.
Statins in primary prevention: the USPSTF guidelines
Two provocative terms in the same line! Statins and the USPSTF! Is Doc Gumshoe stirring the pot to attract attention? Well, the news here is not the recommendations themselves, which have been out for about a year, but the disagreements about the guidelines that were just published in JAMA.
The role of statins in secondary prevention – that is, prevention of acute coronary syndromes in persons with established heart disease – has been solidly demonstrated for at least 20 years. Despite ongoing disputes about potential harms due to statin side effects, it’s clear that in persons who already have established heart disease, the benefits of statin therapy outweigh the harms by a considerable margin. What the U. S. Preventive Services Task Force (USPSTF) is addressing now is primary prevention – prevention of heart disease in persons who do not have established heart disease. The question is, which risk factors should be taken into account in deciding whether to put such persons on statin therapy, and at what risk factor level should statin therapy be introduced?
The USPSTF recommendations loosely follow the guidelines issued by the American College of Cardiology and the American Heart Association. Here’s my summary of the ACC/AHA guidelines, which I sent your way last year.
- They attempt to quantify total cardiovascular risk by arriving at a percentage figure for a ten-year risk of cardiovascular events (heart attack or stroke), based on an algorithm. Individuals aged 40 – 75 whose ten-year risk is 7.5% or higher are recommended to take statins.
- They recommend that persons whose LDL-cholesterol levels are 190 mg/dL or higher should take statins.
- They also recommend that all persons with existing heart disease or Type 2 diabetes should take statins.
- However, specific LDL-cholesterol goals are not part of the new guidelines. According to the guidelines, regular monitoring of blood cholesterol levels is not necessary, and the effects of treatment should not be based on how much cholesterol-lowering takes place.
It was estimated that implementing these guidelines would result in 70 million people in the US being on statins.
The USPSTF didn’t swallow the guidelines whole. They gave a B recommendation for starting low- to moderate-dose statins in persons ages 40 to 75 with a history of cardiovascular disease and a 10-year risk of a signal CVD event of 10% or greater, and a C recommendation if the CVD event risk was between 7.5% and 10%. And for adults over the age of 76, there was no recommendation either way.
The USPSTF has ways of hedging what those recommendations mean – for example, the B recommendation means high certainty that the benefit is moderate and moderate certainty that the benefit is substantial. The C recommendation lowers it to moderate certainty that the benefit is moderate.
The ACC/AHA guidelines were a good faith attempt to deliver potentially beneficial treatment to a very large number of people who were not receiving it. A paper in JAMA Cardiology analyzed data on statin use between 2002 and 2013 and found that, despite a large increase in the percentage of the population taking statins over that period – from 17.9% to 27.8% – there were still large groups who were considered to be undertreated. Women were about 20% less likely to receive statins than men, African-Americans and the uninsured were about 50% less likely to receive statins, and, perhaps most significantly, only 60% of persons with known cardiovascular disease were taking statins.
The doubts raised by many eminent cardiologists focused on two elements of the USPSTF guidelines. One, over-reliance on an algorithm that gave undue weight to the age of the subject, such that an older person with few other risk factors might be placed on statins, while a younger person with more significant risk factors might slip under the wire. And, two, eliminating ongoing cholesterol tests as part of the protocol, based on the assumption that once a person had been prescribed a statin, that person would take the statins for life.
It’s perhaps understandable that when addressing a situation of such huge proportions, the one-size-fits-all approach might seem tempting. But the ACC/AHA guidelines seem to incorporate some contradictions. E.g., a person age 74 with some additional CV risk factors gets a statin prescription, but if that same person presents with those same risk factors at age 76, he/she does not get the statin prescription, because the cut line for the algorithm is age 75. Does the 74-year-old now stay on statins for the rest of his/her life, while the 76-year-old with exactly the same risk profile does not get statins? There is indeed a lack of strong evidence that statin treatment is effective in older persons. Yes, it lowers LDL-cholesterol, but it doesn’t do a whole lot for life expectancy.
And, if the 40-year-old gets put on statin treatment, how do we know, a few years later, if it’s actually doing any good? And, unless that 40-year-old gets some reinforcing information – “Your bad cholesterol is down by about 20 points” – how do we keep that person on the treatment? Adherence to drug treatment is a big problem, and it requires long-term bolstering.
Another issue is that foregoing regular monitoring of cholesterol means that some patients who do not respond adequately to statin treatment will fly under the radar. Such patients might benefit by receiving the PCSK9 agents that typically lower cholesterol by larger percentages.
Some clinicians argued in favor of considering younger patients for statin therapy, on the ground that elevated cholesterol levels and the buildup of atherosclerotic plaque often begins quite a bit earlier than a person’s fortieth year, and sometimes as early as the twenties or even the late teens.
The argument that the USPSTF guidelines are too aggressive emphasized that the real benefit, as measured in terms of CVD outcomes, is not given as much weight as the statistical benefit, as measured in reduction in relative risk. E.g., if the relative risk, according to the algorithm, that a person will experience a cardiac event in the next 10 years is 12%, and statin treatment reduces that risk to 9%, then that relative risk reduction is an impressive 25%, even though the reduction in absolute risk is only 3%. In terms of real outcomes, it has been estimated that statin treatment in patients with no established CVD might prevent two heart attacks per 100 patients during a 5 year period. I repeat – in patients with no CVD.
The clinicians who commented on the guidelines were generally agreed that algorithm-based risk assessment and guidelines-based treatment was not a good substitute for careful individual evaluation of each patient. That’s no doubt obvious, but it runs contrary to the underlying mission of the USPSTF, which – even though they don’t admit it! – is ruled by the God of Cost Effectiveness.
And here’s another bit that marginally concerns USPSTF guidelines.
Androgen deprivation therapy for prostate cancer is linked with dementia
This form of therapy is used only in cases of advanced metastatic prostate cancer, which cannot be treated by other means, such as surgery or radiation. The basis for this therapy is that prostate cancers do not grow in the absence of androgens, which are male sex hormones – testosterone and dihydrotestosterone. Androgen deprivation therapy (ADT) can be achieved either through a number of drugs or by means of surgical castration; most men, understandably, chose drug treatment.
The drugs most commonly used are luteinizing hormone-releasing hormone (LHRH) agonists, including leuprolide, goserelin, triptorelin, and histrelin. These agents permit men to keep their testicles, but reduce the amount of testosterone that the testicles secrete. However, the testicles will shrink over time and may become too small to feel.
Any form of treatment that reduces testosterone has a number of quite serious consequences besides the loss of sexual desire. Besides libido, testosterone regulates the formation of bone and muscle, fat distribution, and the production of red blood cells. Testosterone levels are linked with physical strength and with some emotional responses.
But there appears to be a strong connection between testosterone levels and cognitive function. A study in JAMA Oncology (10/13/16) followed more than nine thousand men with prostate cancer for five years. Almost 8% of men who had received ADT developed dementia, compared with 3.5% of the men who had not received this form of therapy. The increase in absolute risk was more than double (hazard ratio 2.36) in the cohort that received androgen deprivation for 12 months or longer.
Another study, this one in the Journal of Clinical Oncology (02/20/16) found a similar association between ADT and Alzheimer’s disease. In this study, with a median follow-up period of 2.7 years, the increase in the risk of developing Alzheimer’s disease in patients getting ADT was not quite double – depending on the statistical analysis methods used, the hazard ratios were 1.88 and 1.66.
The strong guess here is that testosterone is important to maintaining cognitive function. The mechanism is, at this point, speculative. And there is no evidence that I know of that testosterone supplementation improves cognitive function, nor is there any evidence – again, that I know of! – that eunuchs and castrati (such as the men who used to sing high soprano parts in operas and church choirs) were cognitively impaired. But the association is strong.
How does this have anything to do with the USPSTF? Recall that ADT is employed only in cases of metastatic prostate cancer. Prostate cancer, diagnosed early enough, is effectively treated by other means, such as radiation and surgery, which we have discussed extensively in earlier posts. ADT is used when radiation and surgery will not work, because the cancer has spread beyond the region where it can be addressed by those means. It is an intervention of last resort.
This last resort appears to be required more frequently, particularly since the USPSTF’s recommendation against routine PSA screening was promulgated in 2008 and restated in 2012. The overall incidence of prostate cancer diagnoses rose from 2004 to 2008, and then declined to the 2004 level between 2008 and 2013. Meanwhile, the incidence of metastatic prostate cancer increased gradually from 2004 to 2008, more or less keeping pace with the increased overall incidence of prostate cancer. But then, starting in 2008, the incidence of metastatic prostate cancer increased rapidly while the overall incidence of cancer diagnoses declined. In men aged 55 to 69, the incidence of metastatic prostate cancer increased by 92% during a period when overall diagnoses of prostate cancer remained level.
This does rather seem to point to an epidemic of missed diagnoses, due at least in part to the greatly reduced number of men who have regular PSA screenings. So, perhaps the campaign against PSA screening has resulted in more men needing ADT and, perhaps as a further consequence, more men developing dementia or Alzheimer’s disease.
Naturally, the report about the increased incidence of metastatic prostate cancer was challenged, on the ground that the raw numbers basically meant nothing unless examined in proportion to such factors as total population, and changes in prostate cancer risk factors such as smoking and weight gain, etc. In other words, it’s not necessarily caused by the steep reduction in the number of men who get PSA screening. But, respected authorities, what else changed by 92% in that relatively short time-span?
Doc Gumshoe does not quibble with the underlying reality that the PSA test is not highly reliable. Elevated PSA levels can be the result of other conditions, including benign prostatic hyperplasia, which is common, and infections or inflammations of the prostate, so a single elevated PSA reading may mean nothing at all. Many clinicians prefer to rely on the digital rectal examination (DRE), and, if they feel a hard lump in the prostate gland, then a biopsy follow-up. But DREs can miss early tumors, and regular annual PSAs do provide valuable information, particularly if the PSA levels are increasing rapidly. It seems to me that relegating PSA screening to the scrap heap incurs steep penalties.
Latest on Zika
You already knew, no doubt, that some local transmission of Zika had been reported in Florida, in Miami-Dade County. Now we learn of the first locally acquired case in the state of Texas. The infected person is a woman, thankfully not pregnant, living in Brownsville, which is on the Rio Grande just across the border from Mexico, near the city of Matamoros. Although border crossings both ways across the river are commonplace, the infected woman did not cross the border and did not travel anywhere outside of Brownsville, nor did she have sex with anyone, so it is assumed that she was infected by a bite from the Aedes aegypti mosquito in Texas. As we’ve noted in earlier discussions of Zika, the Aedes mosquitoes do not travel more than a few hundred yards from where they were hatched, so this strongly suggests that there are now Aedes mosquitoes in Texas, and also strongly suggests that these pesky bugs will bite more people, infecting them, and creating a reservoir of infected blood for still more mosquitoes to feast on and transmit the Zika virus.
Now, obviously, one case does not augur an epidemic, and Zika is to some degree a self-limiting infection, since persons who have been infected do develop a degree of immunity and do not function as reservoirs for active virus after their infection has remitted. All the same, it appears likely that there will be more locally transmitted Zika in the Texas Gulf Coast, and that some of the infections will be in pregnant women, and that some of those babies will be born with microcephaly. Of course, it is also possible that the Brownsville case will be a dead end and that there will be no more local transmission.
In the meantime, there continue to be locally-transmitted Zika cases in Florida. The count of locally-transmitted cases is now up to 184. Most of the 4,444 reported cases of Zika in the United States were acquired while the subjects were traveling outside the US. That number includes 1,114 pregnant women, so the likelihood of microcephalic babies is high. We should also assume that the 4,444 number of infections is low; many patients with Zika have mild symptoms and may not seek medical care for what they might assume is a passing episode of flu.
In spite of that not-very-good news, I’ll persist in my view that Zika is not a major threat in the US. Even though the CDC has recommended that all blood donors be tested for Zika as a precaution, the number of blood donors who tested positive has been really tiny. Zika can be controlled through mosquito-eradication programs; window screens and mosquito repellent will protect individuals. Over time, the threat will diminish.
However, some old-time health threats don’t seem to go away. Here’s one that’s still doing serious damage.
Measles killed 134,000 children in 2015
That’s way more than the total number of Ebola deaths, and way, way more than the number of babies affected by Zika. The great majority of those deaths took place in Congo, India, Indonesia, Ethiopia, Pakistan, and Nigeria, where millions of children went unvaccinated. In contrast, in the United States there were no measles deaths between 2002 and 2015, when the first measles death in 12 years was reported. It should go without saying that measles and deaths due to measles are entirely preventable. The vaccine works quite well, and the way it works is not just that it protects the individual vaccinated child, but that it gives the virus no place to hide. People who choose not to vaccinate their children are not only risking the health of their own children, but endangering the health of the community.
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Back in February, Doc Gumshoe did a piece entitled “A Defense Against the Evil Cardiac Killer” in which I argued that the supplement promoted by Dr Arash Bereliani was of little value, and, much more important, that Dr Bereliani’s attack on the Framingham Study and on the conclusion that cholesterol was a major culprit in the formation of atherosclerotic plaque was likely to do more harm than good. A couple of weeks ago, a reader posted a comment in reply to that piece in which he reported that he himself had been treated by Dr Bereliani, and that Dr Bereliani was an honest physician who didn’t push Big Pharma’s phony and expensive cures, but instead prescribed supplements that he believes in. I did not answer that comment directly, but I want here to reiterate the main point, which is that when supplement hustlers steer patients away from established forms of treatment that have been demonstrated again and again to be effective in addressing diseases, and instead urge them to try to cure life-threatening diseases with supplements that have little or no value, it’s not the supplement that does the harm, but the lack of genuine treatment. Of course, not all established treatments are effective in every patient, and some supplements may have some value, but flushing all well-established forms of treatment for heart disease down the toilet while promoting ineffective supplements is not the mark of an honest physician. It is the mark of a heartless scam artist.
An excellent holiday season to all! Best, Michael Jorrin (aka Doc Gumshoe)