57 Comments

"RCT" is a euphemism for blind or double blind study. Those are unethical since they deny consent. Don't give them credence. The placebo effect is overrated.

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Nov 18, 2022
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"Regimental combat team"? We were actually discussing "randomized controlled trials". Sometimes ya gotta look up acronyms if not obvious what the initials stand for. While Establishment, see https://en.wikipedia.org/wiki/Randomized_controlled_trial

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Can you explain how it is that you perceive that an RCT necessarily denies informed consent? Is that because patients are not allowed to know while in the trial if they are receiving a treatment or placebo? I am very interested in the ethics of informed consent, which is why I am asking this question respectfully.

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They do not deny consent. You agree that you will be receiving either the treatment or a placebo and you consent to both these possibilities.

The placebo effect, on the contrary, is still widely underrated because of a bias against the mind-body connection in the West and lack of education. Many do not realize for example that side effects greatly enhance the strength of the placebo effect. This actually means that an RCT by itself is insufficient, with some treatments, to eliminate the placebo effect as a confounding factor. In a trial of an SSRI, where loss of libido is a widely known and very common side effect, close to half the treatment group might become aware that they are receiving the SSRI, and the side effect boosts their perception of the strength of the medication, resulting in a placebo effect much greater than that in the control group. Placebo effect is still a massive factor even in an RCT in some cases.

Yours is a strange criticism. We used to do heart surgery to alleviate angina and it turned out that was all placebo effect. Because we finally did an RCT, there are thousands of useless heart surgeries per year that we do *not* do now. RCTs are the gold standard in public health and medicine.

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Sounds like "gaming" in Vegas and consenting to being an insouciant dumbass. People really do not know whether they suffer angina, so can be hypnotized out of it? Is nitroglycerin also a hypnotic?

Hey, I'll take this as your suggestion both monetary gamblers and participants in these RCTs should be involuntarily committed.

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Yes, please! I believe in D3 with K2 and agree their value is being withheld from the public!

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03 March 2021:

Susceptibilities to COVID-19 severity and complications are driven largely by vitamin D deficiency

https://www.bmj.com/content/372/bmj.n544/rr-1

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Of course doing research on D3 would be extremely beneficial. I remember going to an herbal medicine conference 15 years ago and hearing an oncologist stating that every single cancer patient in his 30 years of practice had low levels of D3. ALL patients. He went on to say that not everyone with low D3 will get cancer but everyone who gets cancer has low D3. Imagine how many people could have avoided cancer had this critical information been available to the general public and all PCPs. I suspect the same would be true of Covid patients.

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My sister recently died of metastasized uterine cancer. Her 25(OH)D level was in the 60s. I DO imagine most cancer patients have low D3; I've seen this myself, as a nutritionist. I assume the oncologist truly had ALL patients with low D3, but extrapolating to ALL cancer patients everywhere should never have occurred.

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It may be the proverbial issue of chicken vs. egg: Is the deficiency due to the illness, or is the illness due to the deficiency? I know about someone with renal cysts, and he cannot get his vit. D level up however hard he tries.

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DOI: 10.1002/1878-0261.12924

Molecular Oncology 04 February 2021 Research Article

Vitamin D supplementation to the older adult population in Germany has the cost‐saving potential of preventing almost 30 000 cancer deaths per year

Tobias Niedermaier, Thomas Gredner, Sabine Kuznia, Ben Schöttker, Ute Mons, Hermann Brenner

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No. There’s no money in it. The public won’t believe it (because it’s cheap and not “approved”). B.Ph. would sabotage it because there’s no money in it.

D deficiency is, in my layperson’s opinion, complex. Too much indoor time? Too much sunscreen? Not enough eggs and salmon? Clothing choices due to climate or religious reasons? How much K2 is needed? D liquid drops or solid? 1,000 IU each hour or one large dose all at once?

I don’t know.

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Nov 18, 2022
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Big Pharma

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You raise some interesting questions. All would need to be looked at. I would add to the list a lipid liposomal delivery of the D3 as a test condition also.

So many variables to consider. Not to mention most everything everyone who commented has already said.

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If you do an RCT on Vit. D it will be roundly ignored (if positive). Might not be a good use of resources.

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It won’t be ignored by everyone. Science is not a popularity contest.

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Can we please put to rest the reality of EBM (evidence based medicine) The information has been available for 20 years, by those in a position to know what really is going on.

As you likely know, two of the most prestigious journals of medicine are The Lancet and The New England Journal of Medicine (NEJM).

Dr. Marcia Angell, Harvard physician and editor in chief of the NEJM said:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor.”

Dr. Relman, another former editor in chief of the NEJM said this in 2002 - “The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”

Richard Horton, editor in chief of the Lancet said:

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness” (2). Horton R. Offline: What is medicine’s 5 sigma? [Last accessed August 5, 2015]. www.thelancet.com. Available from: http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960696-1.pdf.

Until this issue is finally addressed, EBM is not the instrument that could have changed scientific inquiry. It's the best example of fraud in scientific investigation. The lack of transparency and misrepresentation of the scientific process has crippled the discovery of medicine and the regulator capture of our pubic health agencies has become the nail in the coffin of science.

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NAILED IT!!!!

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Recognizing corruption and monied interest in scientific publications isn’t a reason to abandon the practice of scientific study.

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No, it means question everything and brace for impact.

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Question everything—obviously. And to be clear, the words of Marcia Angell and Richard Horton has been out there for a long time, no argument there.

But the post is asking a question that deserves an answer. I would vote yes. And that’s regardless of the state of Evidence Based Medicine. Yes, the big journals are corrupted and engaged in fraud. All the more reason to do good, solid, uncompromised studies—and Vitamin D is so fundamental to the immune system, I’d say it’s a worthy investment of effort.

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That's the most insightful comment I've read in ages... well said!

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There is no money in health. But there's lots of money in selling snake oil to people that have been deliberately made sick by poisonous foods, excessive carbohydrates and dangerous pharma products.

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Hi Dr. LW,

Very glad you are asking the question.

The quality of the vitD research has improved greatly during the last three years, including some very interesting prospective studies (Castillo, et. al 10.1016/j.jsbmb.2020.105751) which looked at ICU admissions. There was a very large effect size in this study, yet it remained suppressed as insignificant due to the sample size. I don't think that that is the case, as the recommendations for Phase III trials using repurposed drugs were to use a sample size of 100. Would like to learn if I've interpreted that correctly or not. I did a critical appraisal on this study for my research methods course and the faculty member overseeing the course published a piece (video) by Medscape to my classmates prior to my presentation....allowing for no discussion afterwards about it. In my view it was a hit piece, but I never had the opportunity to explore that civilly with my classmates. Hmm. That would require freedom of speech.

Sunil Wimalawansa, MD Prof. em. and endocrinologist was the primary author of the FLCCC's vitD dosing table which was published in the last year. His piece in Nutrients is here: https://doi.org/10.3390/nu14142997. William Grant, PhD and Patrick McCullough, MD also published good predictive mechanistic papers early on, but Dr. Wimalawansa's is a good up to date review.

A lot of quiet work has been done behind the scenes by the indomitable citizen scientist Robin Whittle to get this information onto broader platforms. He and Patrick Chambers, MD submitted vitD recommendations to HMG here:

UK-OHID-Vitamin-D-RW-PWC.pdf. On Robin's website vitaminDstopsCOVID.info you can find an invitation to join NIOSH, a group of vitD researchers. If you choose to prioritize this research, please join us there.

The great thing about IPAK conducting the research is that it could design the study properly so that one would measure the impact related to serum 25(OH)D levels and not the dose given; as the bioavailability varies widely, as you know.

At our practice we have been monitoring vitD levels closely since 2020 and titrating to a level that reflects the literature in terms of immune protection. Of existing patients on vitD, there was no mortality from COVID. The literature has shown those with levels > 50 ng/ml do not enter ICUs nor die.

I would like with you to review the history of the vitamin D IOM recommendations. I'm swamped with school stuff at the moment or I would fish out the citations, but there is a policy paper waiting to be written to expose the public health debacle that was predictable. Perhaps Henry Ealy has already covered this in his long piece on COVID a couple of years ago. If you are interested to review this, let me know.

I would love to see fourth grade children understand the cellular biology of vitD, the VDR, the epigenetic changes made by vitD and the role of cathelicin as a self-generated antibiotic. It would make great 'back-of-the-cereal-box' reading at the breakfast table.

There is so much waiting for people to discover regarding their health that is inexpensive and very protective. I am grateful for your work/IPAK. Happy Thanksgiving.

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Couldn’t have said this better!

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I am an ARNP, not a scientist and currently not working in a clinical role where I have an option to test this out. But I would love to be more involved in this vitamin D research.

I can be reached at my email mariecaseyburke@yahoo.com

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Marie, we would welcome you to the NIOSH group. A lot of good scientists there.

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Hi Carol,

How can I find out more about this NIOSH group?

Sorry it’s taken me this long to respond. Somehow this had gotten buried in my yahoo emails

Thanks,

Marie

my email is : npmarie93@gmail.com

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Go for it! We absolutely need RCT trials on generics. What better way to send a giant F.U. to our Big Pharma overlords?

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Many years ago, European population based studies documented widespread deficiencies in Vitamin D - worse in the northern latitudes. among dark skinned people, and during Winter. The investigators also documented a higher attack rate of wintertime viral respiratory disease.

So; available evidence should have prompted widespread supplementation with D3 from the beginning of the pandemic. CDC seems to forget that "Prevention" is part of their official name.

The VA study is a good one.

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Yes. There is a new campaign by government against D3. I think it could stage a dangerous pressure against health care providers recommending D3 as a supplement

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Yes please do the research b/c others won’t!

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The fashionable "science" is always undertaken without controls these days.

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I'm sorry to hear about your sister. Can you share whether she had been vaccinated for Covid? I am so grateful that husband avoided the Covid jabs and was able to get a medical exemption from a forward thinking physician. Today, I don't think one could get an exemption for cancer as that's one of the big diseases where they push the jab unfortunately. I don't believe we need an RCT when oncologists around the country are seeing evidence of this in their patients. Given the scientific fraud in the journals, I no longer have any confidence in these clinical trials. This was confirmed by editors in chief of leading medical journals.

Are you saying that when she was first diagnosed, her level was 60? My husband hadn't been taking D for quite a while and then after an exam, when possible prostate cancer was identified, he starting taking high doses of D. When he got a firm diagnosis a month later, he had his labs done and his level was also around 60. I believe he increased his level significantly during that month so the labs from the month later weren't able to assess what his level might have been from prior months. In theory I agree with you but this oncologist had seen 20,000+ patients so his results are certainly meaningful but not definitive.

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Dandelion root would be natural remedy for prostate issues; there will be sources and studies available on search.

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JLW, I would actually advise against doing an RCT of vitamin d for several reasons. Firstly there are some small number of rcts that don't look that great. Secondly there's enough awareness about vitamin d that there are going to be rcts and a systematic review eventually anyway. Thirdly multiple reviews have found no association between vitamin d levels and severity. Fourthly everyone is completely confused about vitamin d science in general. It is neither generally safe or generally effective for just about anything. There are more than 70 types of vitamin d and nobody understands squat about the metabolism. 2/3rds of the metabolites are literally not even on the metabolic path following supplements. And the most potent anticovid metabolites may be lumisterols which you can only make from sun. There are certain subset of people, myself included, who are severely harmed by vitamin d supplements because it has interaction with undiagnosed ubiquitous chronic infections. In people who have so-called low vitamin d, the so-called active vitamin d is frequently high. This is not deficiency. this is dysregulated metabolism and a disease process.

Low vitamin d does not cause disease. Disease causes low vitamin d. Taking vitamin d can be pouring fuel on a fire.

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I've actually not seen "multiple reviews finding no association between vitamin D levels and severity," but I would be very curious as to how they were set up.

The single study I saw that found no benefit from vitamin D as Covid treatment had a very curious setup, wherein the Covid patients weren't given the treatment until the 10th day of hospitalization (a wee bit late, right?), and then they were given a singly whopping high dose of 200,000 IU, orally, in peanut oil. Hell, I'd have trouble keeping that down, and I'm not sick.

You make an interesting point about D supplements having interaction with undiagnosed ubiquitous chronic infections. How many people have these chronic subclinical infections, and what proportion of them have high levels of active D? Are there studies you can post?

Seems to me that the appropriate path would be to test for D levels before treating, and to further screen people likely to HAVE chronic infections.

I had low D at one time, and ignorant doctors tried to diagnose me with a "syndrome" (that would have called for repeat visits and medications), and it turned out all I had was D and B12 deficiencies, which were CAUSING my "disease" process. I would hate to see others go through that unnecessarily.

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- Here is a start:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160567/

Autoimmunity Research Foundation, Trevor Marshall, and Amy Proal are places to look into.

- Surveillance of chronic infections is not even in its infancy. Their presence has to be inferred at this point from observations such as the messed up vitamin D ratio.

- No doubt studies can be designed poorly

- There is no such thing as testing for low D, as vitamin D deficiency is literally not a defined entity. The idea that low 25D levels is a deficiency is 100% arbitrary and makes no sense. If it were, than vitamin D trials would work for everything, when in reality 90%+ of RCTS of vitamin D for anything under the sun say it does not work. There are at least 10 types of 25D. Which one is measured? Can't find a single person who can answer that question as of today. It's mostly in the fat/bones/muscles/organs, not the blood. And your body regulates the blood levels just fine. And some of it is protein bound and some not. And all the benefit is supposedly ascribed to the active 1,25D which has NEVER once been documented as being pervasively low in any study. 1,25D levels are not even seasonal. Plus there are sulfated D3's in the blood which are as abundant as 25D, and it seems 25D CANNOT be converted into them, whereas the reverse direction may be true. Meaning even the 25D "storage" itself has a prior storage molecule...Nothing about D deficiency narrative makes sense.

- D pills are potentially potent experimental immune altering substances. I have no doubt that will result in some people feeling better. But these people, such as yourself, are 100% not predictable, and for every one such person, there is likely another who was made that much sicker. And those who benefit are not benefiting because of the correction of any mythical deficiency.

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I don't see you supporting any of your claims with evidence, despite your confident assertions.

The study you linked is long on hypothesis, and short on provable fact. Yes, we make enough D from sunshine -- but the authors fail to specify that this is true from September - May only for those who live below the 37th parallel. See https://www.health.harvard.edu/staying-healthy/time-for-more-vitamin-d

The quote claiming that "increases in 25(OH)D have no effect on inflammatory processes or on disorders at the origin of these processes" is footnoted to reference 64, which appears to be an error, as it does not include that quote. At any rate, this study certainly refutes that claim: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070857/

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- I'm not gonna produce a literature review on the fly.

- You have it all backwards. "Enough" vitamin D? According to what? Vitamin D deficiency is not even a defined thing. All they have is correlations of one of 70+ metabolites. The provable fact that needs to be provided is that low 25D levels actually cause disease. The fact that 25D is seasonal is in and of itself meaningless.

- I never stated 25D has no effects on the immune system. It does, but those could be positive or negative, and exist apart from any mythical deficiency. The study you link is just doing correlation=causation again, which is wrong.

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You wrote"here is a start," and linked to a study quoting the claim of no effect on inflammatory processes.

Apparently, you didn't read it.

Seems like the general consensus is that Vitamin D deficiency has been defined.

As with most vitamin deficiencies, as more is learned, parameters change and definitions adjust.

"Definition of vitamin D deficiency

Serum 25(OH)D is considered to be the best marker for assessing vitamin D status, and reliably reflects the free fractions of the vitamin D metabolites, despite the fact that, in theory, the bioavailable fractions may be more clinically informative [9, 10]. A range of below 75 nmol/L (or 30 ng/ml) of serum/plasma 25(OH)D concentration is considered vitamin D deficiency by most authors [11, 12]. A cutoff of <25 or <30 nmol/L (or 10/12 ng/ml) increases the risk of osteomalacia and nutritional rickets dramatically, and therefore is considered to determine severe vitamin D deficiency [13,14,15,16]. The clinical practice guidelines of the Endocrine Society Task Force on Vitamin D [12] have defined a cutoff level of 50 nmol/L as vitamin D deficient. Furthermore, different societies and expert bodies have defined 50 nmol/L as “vitamin D requirement of nearly all normal healthy persons,” by using bone health as the main basis. For example, a cutoff level of 50 nmol/L is recommended by the Institute of Medicine (IOM, USA) in their “Dietary Reference Intakes”. Vitamin D levels of <30 nmol/L (or 12 ng/ml) should likely be prevented with a public health approach [17]. There are many large and relevant risk groups for vitamin D deficiency (Table 1)."

https://www.nature.com/articles/s41430-020-0558-y

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- I linked the study because you asked about infection and elevated 1,25D, which it speaks to. Never said 25D doesn't do stuff.

- The consensus is also that vaccines are safe. I don't care about consensus. Need logic and evidence.

- As I have stated, there is no basis to the definition you quote. Totally arbitrary and based on unfounded correlation=causation logic. You need to ask yourself how they even get those numbers. And mind the assumptions you make in arriving there. No correlation=causation nonsense.

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