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Vitamin D on Trial

Prevention trials for vitamins and supplements are notoriously difficult, but some researchers aren’t giving up on finding proof that vitamin D helps ward off disease.

By | March 1, 2012

image: Vitamin D on Trial Harry Campbell

HARRY CAMPBELL

Once a month for the next 5 years, 20,000 people across the United States will find a package containing 62 pills in their mailboxes.  As participants in a clinical trial, the recipients agreed to swallow two of the pills daily. But inevitably as the years pass, some pill packets will become buried under a stack of letters, or forgotten in a drawer.  After all, these pills contain only vitamin D, fish oil, or an inert placebo—a person doesn’t need them to make it through the day.  Plus, no one monitors who takes the pills daily and who does not.

In another study, 871 pregnant women swallow a vitamin D or a placebo pill every day for the duration of their pregnancy. Then every year for 3 years after they’ve given birth, clinicians will evaluate their children for signs of asthma, in search of clues about the relationship between the essential vitamin and the respiratory disorder. But the study is scheduled to last only 3 years, so it won’t include children who begin to wheeze at age 6, when childhood asthma most often strikes.

A better vitamin D trial might send health-care professionals out to personally deliver pills to each of the first trial’s 20,000 participants. It might also test various doses of supplements, because no one knows how much is best. The asthma trial might include more women, run for a longer period of time, and test childhood supplementation, too. But then they’d also cost millions more, and in contrast to many drug trials, Pharma isn’t footing the bill. Profits from vitamin sales pale in comparison to those of most drugs, and therefore a company would struggle to recoup the money it spent testing supplements. Unfortunately, prevention trials require large sample sizes and long-term follow-up, making them incredibly expensive. Indeed, the National Institutes of Health has granted about $32 million for these two trials alone.

But researchers aren’t giving up. With limited budgets, vitamin D investigators are working hard to keep costs down, while still giving the vitamin a fighting chance to prove itself. Deficiencies of vitamin D have been linked to cancer, diabetes, strokes, and other maladies, and at least 12 imperfect clinical trials on its preventive powers have been set in motion since 2008. And while some scientists worry their cost-trimming shortcuts will render the results useless, others remain optimistic. Perhaps this smorgasbord of trials will reveal unpredictable benefits of taking one’s vitamins.

Enticing observations

In 2008, epidemiologist JoAnn Manson at Harvard Medical School in Boston received NIH funding to lead the largest vitamin D intervention trial yet. In observational studies, Vitamin D had shown promise for lowering the risk of a wide range of diseases, but Manson felt the field would benefit from a large clinical trial that more rigorously tested the vitamin’s power. This sentiment only grew when she analyzed about 1,000 reports on vitamin D metabolism, intake, and impact on human health as a member of a panel convened by the Institute of Medicine (IOM) in 2009. The panel decided that while the benefit of the nutrient for bones is real, helping to promote bone strength while staving off diseases such as rickets, osteomalacia, and osteoporosis, the evidence of nonskeletal benefits was inconclusive[1. Institute of Medicine, Dietary Reference Intakes for Calcium and Vitamin D, National Academies Press, 2011.]—an uncertainty that continues to linger.[2. M. Chung et al., “Vitamin D with or without calcium supplementation for prevention of cancer and fractures: An updated meta-analysis for the US Preventive Services Task Force,” Ann Intern Med, 155:827-38, 2011.]

The decision infuriated many scientists—some of whom had documented the correlation between high blood levels of vitamin D and lower rates of colorectal cancer, diabetes, asthma, influenza, multiple sclerosis, and an array of other ailments. And in many cases, researchers can point to ways the vitamin might bring about benefits. The hormone derived from vitamin D, called 1,25-dihydroxyvitamin D3, or calcitriol, can turn on or off hundreds of genes in the body, thereby participating in processes ranging from cell proliferation to immune system regulation. But the IOM panel concluded that without large-scale prevention trials confirming the ultimate result of high levels of vitamin D, it could not say for certain whether insufficiency contributes to cancer or any other nonskeletal disease.

Others argue that the correlational studies provide enough evidence to recommend that people maintain a higher concentration of vitamin D in their blood, and that difficult, expensive, and often inconclusive prevention trials, particularly those for relatively rare or unpredictable diseases, are a waste of time. “The success of the RCT [randomized controlled trial] in evaluating medical treatments has, perhaps, blinded nutritionists, regulators, and editors to the fact that it is a method ill-suited for the evaluation of nutrient effects,” Robert Heaney, an endocrinologist at Creighton University School of Medicine wrote in a 2008 commentary published in The Journal of Nutrition.[3. R.P. Heaney, “Nutrients, endpoints, and the problem of proof,” J Nutr, 138:1591-95, 2008.]

And it seems the public isn’t waiting for clinical trial data. Spurred by headlines about its potential benefits, US consumer sales of vitamin D supplements rocketed from $50 million in 2005 to $550 million in 2010, according to estimates from the Nutrition Business Journal. Enthusiasm for the vitamin echoes among doctors and natural-food advocates, who are pushing for doses higher than the 400 to 600 International Units (IU) that the government currently recommends for maintaining healthy bones.

However, Manson, a refined woman of measured words, is acutely aware of the disappointment that has trailed the hyping of vitamins over the decades. Vitamin E, a fat-soluble antioxidant, gained a reputation for fighting cancer in the 1990s, when observational studies found that people who took supplements had lower rates of the disease.  But the buzz died out in 2008 when a 35,000-person clinical trial on vitamin E and selenium was terminated prematurely after people taking the supplements showed a slightly higher risk of developing prostate cancer than the control group. Similarly, in 1996 two large clinical trials dumbfounded fans of beta-carotene, a substance that humans convert into vitamin A after consuming it in fruits and vegetables. One trial found that it raised the risk of lung cancer and heart disease, and the other ended anticlimactically after 12 years with the conclusion that beta-carotene supplements performed no differently than placebo. “You have to look at these previous randomized trials as cautionary tales,” Manson says, “because they show that time and time again, everyone jumped on the bandwagon and then the randomized trials did not have favorable results, and in fact, the risks outweighed the benefits.”

At the same time, however, this is exactly why large-scale trials are necessary, she says. Though they aren’t perfect, such trials are the only way to discover whether vitamin D causes better health, or simply indicates it. “For example, people who are physically active tend to spend more time outdoors walking, hiking, or playing tennis. They get more sun exposure”—and thus more vitamin D—“but the real benefit might be physical activity,” says Manson. “There are so many potential confounders, and this is just one we know about.”

Infographic: Suspected Effects of Vitamin D  View full size JPG | PDF
Infographic: Suspected Effects of Vitamin D
View full size JPG | PDF
HARRY CAMPBELL

Manson designed her 5-year, $22 million study, called VITAL (VITamin D and omegA-3 triaL), to be cost effective. For a point of comparison, VITAL costs just $200 per person per year, whereas a rate of at least $1,000 is typical for many nutrient trials, Manson says. Rather than require in-person visits for all 20,000 participants, she decided to mail the participants their pills, in four randomized combinations—either 2,000 IU of vitamin D3 and 1 gram fish oil (omega-3 fatty acid), one of those plus a placebo, or two placebos—to be taken daily. In addition to reducing costs, she says this lessens the burden on busy participants. And in order to increase the chances that the trial would detect an effect, the participants are all over age 50, and therefore more likely to develop a disease. Furthermore, in addition to cancer and heart disease, VITAL investigators will assess dozens of other outcomes. They’ll learn when patients are diagnosed with cancer, diabetes, and other diseases, and in a subset of the participants, periodic clinical visits will allow doctors to measure blood sugar levels, cognitive performance, lung function, heart function, muscle strength, weight, and much more.

Delicate dosing

Time and time again, everyone jumped on the bandwagon and then the randomized trials did not have favorable results, and in fact, the risks outweighed the benefits.
—JoAnn Manson, Harvard Medical School

Scientists critical of the VITAL study question whether the daily dose of 2,000 IU is enough to distinguish the treatment group from the controls. If this were a drug trial, the placebo group would go without the drug completely. But it’s unethical to ask anyone to go without vitamin D. Doctors inform all participants that they can take up to 800 IU of vitamin D daily (the national recommendation for people over 70 years old) in addition to the pills they receive in the mail. If they do, the control group will sustain more than adequate levels. But some participants might decide to break the rules and head to the nearest corner store for high-dose supplements after being told that vitamin D may help prevent cancer and other diseases. And of course, many participants won’t follow through with taking the pills they’ve been sent in the mail. “You hope drop-ins and drop-outs will be equal on both sides, but they may not be,” warns biostatistician Gary Cutter at the University of Alabama at Birmingham.

A higher dose of vitamin D would widen the gap between the treatment and the control group, but Manson isn’t swayed. She says 2,000 IU will lift the treatment arm well above the level suggested to help protect against nonskeletal diseases, while she expects the controls to stabilize at levels sufficient for healthy bones. “Sure, we could have tested higher doses, but then right off the bat, we might have had safety issues,” Manson says. Indeed, the trials that found harm in vitamin E and beta-carotene have been criticized for testing too high a dose. Furthermore, elderly participants in two independent clinical trials fell more often when they received whopping doses of vitamin D once a year[4. K.M. Sanders et al., “Annual high-dose oral vitamin D and falls and fractures in older women,” JAMA, 303:1815-22, 2010.] or once every 3 months5—although in the latter study the effect was not statistically significant.

Nonetheless, in other disease-prevention trials, investigators are gunning for better compliance and a fighting chance of showing an effect by doling out large, periodic doses of vitamin D. In the United Kingdom, a trial looking at the effect of vitamin D on respiratory infections (including the flu) is giving participants 120,000 IU of the vitamin every 2 months. And participants in the treatment arm of a vitamin D trial for type 2 diabetes prevention take an average dose of 89,684 IU once per week. Despite the rather extreme dose, none of the first 50 participants to hit the 6-month mark in the diabetes trial have had increased calcium in their blood and urine—the first sign of harm to bubble up in vitamin D studies, says lead trial investigator Mayer Davidson of Charles Drew University of Medicine and Science in Los Angeles. And those enrolled for 2 months in the UK trial also have normal blood calcium concentrations.

Davidson chose the high dose—one that some researchers call potentially dangerous—to ensure that if the nutrient does in fact affect glucose metabolism and prevent diabetes, he’s sure to catch it. Plus, the participants in the study require more vitamin D than usual because most of them are obese, and fat serves as a sink for fat-soluble vitamins. In addition to their weight, the people Davidson’s team recruited have other risk factors for diabetes: they’re African American or Latino; diabetes runs in their families; they have high blood pressure and impaired glucose tolerance or impaired fasting glucose, also called pre-diabetes; and they had low blood levels of vitamin D before the study began. Likewise, Anastassios Pittas at Tufts University plans to enroll patients at risk of diabetes in another prevention trial, in which he and his team will administer 4,000 IU of vitamin D daily.  By enrolling at-risk populations, Davidson and Pittas hope to see an effect on diabetes with just hundreds of participants within a few years’ time.

Investigators who study relatively rare diseases face the biggest challenge. In December, multiple sclerosis (MS) researchers gathered in Chicago to plot a trial to prevent the debilitating disease characterized by excessive inflammation and nerve damage. But because fewer than eight people per 100,000 in the United States acquire MS each year, hundreds of thousands of healthy individuals would need to enroll. Plus, while MS usually occurs sometime between ages 25 and 40, vitamin D’s putative protective power could begin in the womb, requiring a trial to run for decades to notice such effects. “It’s an unfortunate time to get funded for a long-term prevention trial,” says Cutter, a self-described skeptic, after attending the meeting. “We might have to do minimalist data collection and give up a lot of things we want to know. Even a 5-year study is very expensive,” he says, “and 5 years might not be enough.”

Adrian Martineau, at the Centre for Primary Care and Public Health of the Barts and The London School of Medicine and Dentistry, faces an analogous hurdle. He says that latent tuberculosis infections seem to activate less frequently in people who have plenty of vitamin D. But because latent infections only become active 5 percent of the time, a trial in the United Kingdom that randomizes 14,000 people with latent infections would still not be large enough to demonstrate the effect of supplements, he says.

Thus, the need for evidence from clinical trials places researchers who focus on tuberculosis in industrialized countries, MS, or other relatively rare disorders in a complicated position. But many researchers continue to push for such trials. George Ebers, a neurologist at the Wellcome Trust Centre for Human Genetics in the United Kingdom, for example, is sure that supplements could prevent some cases of MS, based on observational studies and experiments that show how vitamin D tames inflammation in animal models. Now he just wants a clinical trial to prove it. “It’s mainly about convincing other people at this point,” he says.

Personalized prevention

Only a few vitamin D trials have assessed nonskeletal diseases thus far, and their combined verdict is inconclusive. One of those trials, aimed at testing fractures, found that vitamin D combined with calcium helped prevent breast, lung, and colon cancers and leukemia, though the result was not one investigators had designed the trial to test, and it was determined from a small sample size. On the other hand, a randomized clinical trial, conducted as part of a large-scale and multifaceted investigation called the Women’s Health Initiative, concluded that vitamin D and calcium supplements didn’t reduce cancer incidence or mortality, and appeared to increase the risk of urinary tract stones.[5. P. Glendenning et al., “Effect of three-monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility, and muscle strength in older postmenopausal women: A randomized controlled trial,” J Bone Miner Res, doi:10.1002/jbmr.524, 2011.] However, critics of this study point to the high rate of dropouts, and the low dose of vitamin D given to the treatment group (just 400 IU daily). And they say the urinary tract stones could be due to the calcium taken alongside vitamin D.

But the Women’s Health Initiative trial wasn’t a complete failure for proponents of vitamin D, as signals of a positive effect of the vitamin have begun to emerge from the data. For example, women in the treatment group who had not been taking vitamins before the trial began did show diminished rates of breast and colorectal cancer.[6. M.J. Bolland et al., “Calcium and vitamin D supplements and health outcomes: A reanalysis of the Women’s Health Initiative (WHI) limited-access data set,” Am J Clin Nutr, 94:1144-49, 2011.] Because investigators hadn’t designed the trial to detect this outcome a priori, however, the results need to be confirmed in a new clinical trial. That said, it brings science closer to understanding how and when vitamin D matters, says John Milner, chief of the National Cancer Institute’s Nutrition Science Research Group.

Indeed, answers may never be simple when it comes to nutrition. One reason why studies have arrived at conflicting conclusions may be that individual needs vary, says Milner.  He hopes that ongoing trials, despite their imperfections, will help unravel the contributions of genetics and diet. “There is some evidence that individuals with certain genetic variations require more vitamin D because they have an inability to absorb or metabolize vitamin D effectively,” he says. And because nutrients interact, a person’s diet also has the potential to alter the effect of supplements. Notably, unlike most clinical trials, which tend to enroll health-conscious Caucasians, the medley of vitamin D trials currently taking place has attracted a diversity of people. African Americans account for 43 percent of participants in the trial on childhood asthma and 25 percent of Manson’s VITAL trial (if all goes according to plan), while Latinos comprise 85 percent of Davidson’s type 2 diabetes trial members. This composition of participants will help researchers determine whether certain ethnicities, or even smaller subsets of individuals, are more responsive to vitamin D supplements than others—a situation that might mask any effects of the vitamin in more homogenous trials.

“In nutrition we talk about maintaining normal adequacy, but some people may require more vitamins than others, and identifying those populations will really be the future of nutrition,” says Milner. “It’s the classic ‘one size does not fit all.’ I’m hoping we can identify biomarkers that tell us who will really benefit, and who doesn’t need to worry.”

Vitamin D prevention trials for nonskeletal disorders

Prevention trials make drug trials look easy. They require more participants and a longer duration, and investigators must trust that the participants take the vitamins they’re given, and don’t decide to up their dose by buying over-the-counter supplements. Below is a list of ongoing trials that are trying to beat the odds to conclusively nail down the benefits of vitamin D for nonskeletal disorders, such as cancer, heart disease, and diabetes.

NAME OF TRIAL PRIMARY OUTCOME START DATE DURATION OF TREATMENT STATUS NO. PARTICIPANTS/
EXPECTED ENROLLMENT
DOSE OF VITAMIN D3
NCT01169259 All cancers, heart disease, and stroke July 2010 5 years Recruiting participants 20,000 healthy men over 50 and women over 55 2,000 IU daily
To be announced (lingering ethical approvals have delayed the official listing of this trial) nfections, cognitive decline, blood pressure increase, decline in muscle strength, risk of non-vertebral fractures June 2012 3 years Approved 2,000 men and women over 70 who have had a fracture or a fall 2,000 IU daily
NCT01052051 All cancers Jan. 2009 4 years Ongoing 2,332 healthy postmenopausal women over 55 2,000 IU (and 1,500 mg calcium) daily
NCT01463813 All cancers and cardiovascular disease Jan. 2012 4 years Approved 18,000 healthy men over 60 and women over 65 3,200 IU or 1,600 IU daily
NCT00920621 Asthma or recurrent wheeze at 3 years old Sept. 2009 1 year Ongoing 871 pregnant women whose babies have a family history of asthma, eczema, or allergic rhinitis 4,000 IU daily
NCT00685594 Type 2 diabetes March 2008 5 years Ongoing 517 adults with impaired glucose tolerance 20,000 IU per week
NCT00876928 Type 2 diabetes March 2009 1 year Ongoing 186 Latino and African American adults over age 40 with risk factors for diabetes Dose determined by BMI; average dose is 89,684 IU per week
NCT01069874 Influenza and other respiratory infections March 2010 1 year Recruiting participants Approx. 290 permanent residents or staff at 116 independent living units 120,000 IU once every 2 months


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Correction (March 6, 2012): The illustration, "How the Body Processes Vitamin D," has been relabeled to correctly reflect that food products are a source of both the D2 and D3 forms of vitamin D. The Scientist regrets the error.

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Avatar of: Foy

Foy's ReVita Water

Posts: 1457

March 1, 2012

In these alleged trials where vitamins D & E were tested and suddenly people began getting 'cancers'--did all these humans live in the same area, drinking and bathing in the same water supply?  Were their home water supplies tested, along with any other personal environmental hazards?  

Because for example, according to public record--in Los Angeles they're "potable" water contains Chloroform, Arsenic, Chlorine dioxide, Carbon tetrachloride, Chromium, Manganese, and Chromium.  This is a partial list--the list of chemicals NOT TESTED is much longer than what has been tested.  Exposure to any of these 'positively tested' chemicals are linked to organ failure & disease--Chromium, Carbon tetrachloride & Chloroform are directly linked to lung cancer.  Without proper monitering of their drinking/bathing water supply, I'd say deflating this project without proper evidence PROVING that they weren't contaminated elsewhere is remiss at best.  

Also, not testing subjects for proper levels of other essential minerals like Magnesium is also critical. Since the onslought of Genetically Mutated foods, important vitamins & minerals could suddenly have become ABSENT from their diets leaving them WIDE OPEN to calcium binding/deposits and other Mag-affected vitamin deprivation, that could easily have led to countless diseases and disorders. If these tests were performed in the 90's(when GMO's were first tested/experimented with/introduced) then these Mutated 'foods' definitely could have had a profound effect. Further considering Theobald Smith's work, the grain overload(and protozoa overload) in GMO corn fed cattle--and that parasites are the very source of EVERY INFECTION--it isn't difficult to believe that any and all of these could have seriously affected the final testing result.

Though I must say--dismissing vitamins as 'savior' is classic Government low-IQ pessimism...always leading with left-brain "critical" logic first. Right brain is necessary to 'see' the patterns of goodness in vitamins. But in a patriarchal society, access to proper thinking is sorely hard to come by.

Avatar of:

Posts: 0

March 1, 2012

In these alleged trials where vitamins D & E were tested and suddenly people began getting 'cancers'--did all these humans live in the same area, drinking and bathing in the same water supply?  Were their home water supplies tested, along with any other personal environmental hazards?  

Because for example, according to public record--in Los Angeles they're "potable" water contains Chloroform, Arsenic, Chlorine dioxide, Carbon tetrachloride, Chromium, Manganese, and Chromium.  This is a partial list--the list of chemicals NOT TESTED is much longer than what has been tested.  Exposure to any of these 'positively tested' chemicals are linked to organ failure & disease--Chromium, Carbon tetrachloride & Chloroform are directly linked to lung cancer.  Without proper monitering of their drinking/bathing water supply, I'd say deflating this project without proper evidence PROVING that they weren't contaminated elsewhere is remiss at best.  

Also, not testing subjects for proper levels of other essential minerals like Magnesium is also critical. Since the onslought of Genetically Mutated foods, important vitamins & minerals could suddenly have become ABSENT from their diets leaving them WIDE OPEN to calcium binding/deposits and other Mag-affected vitamin deprivation, that could easily have led to countless diseases and disorders. If these tests were performed in the 90's(when GMO's were first tested/experimented with/introduced) then these Mutated 'foods' definitely could have had a profound effect. Further considering Theobald Smith's work, the grain overload(and protozoa overload) in GMO corn fed cattle--and that parasites are the very source of EVERY INFECTION--it isn't difficult to believe that any and all of these could have seriously affected the final testing result.

Though I must say--dismissing vitamins as 'savior' is classic Government low-IQ pessimism...always leading with left-brain "critical" logic first. Right brain is necessary to 'see' the patterns of goodness in vitamins. But in a patriarchal society, access to proper thinking is sorely hard to come by.

Avatar of:

Posts: 0

March 3, 2012

I wonder at the point of trials isolating vitamins like this.  Clearly a person's health can be affected by deficiencies in any vitamin, mineral or essential fatty acid.  When selecting individuals for trials, it's self-evident that their state of health will vary dramatically and their base level of vitamin, mineral and essential fatty acid will similarly vary.  What effect will increasing the amount of a single vitamin on the overall health of these individuals?  Is it possible that people who aren't helped or are negatively affected by taking this vitamin in isolation are actually deficient in an important co-factor for the vitamin and so can't benefit from increased intake? Are all vitamins created equal?  I.e. are some vitamins more important for overall health than others, e.g. folate, B12, B6, vitamin C, etc.?  I think wider research into nutritional supplements needs to be better focused and funded by government because pharma companies certainly won't do it.

Avatar of: jim_herd

jim_herd

Posts: 1

March 3, 2012

I wonder at the point of trials isolating vitamins like this.  Clearly a person's health can be affected by deficiencies in any vitamin, mineral or essential fatty acid.  When selecting individuals for trials, it's self-evident that their state of health will vary dramatically and their base level of vitamin, mineral and essential fatty acid will similarly vary.  What effect will increasing the amount of a single vitamin on the overall health of these individuals?  Is it possible that people who aren't helped or are negatively affected by taking this vitamin in isolation are actually deficient in an important co-factor for the vitamin and so can't benefit from increased intake? Are all vitamins created equal?  I.e. are some vitamins more important for overall health than others, e.g. folate, B12, B6, vitamin C, etc.?  I think wider research into nutritional supplements needs to be better focused and funded by government because pharma companies certainly won't do it.

Avatar of: Underpressure

Underpressure

Posts: 2

March 6, 2012


There is a mistake in the article. The no 2 picture tells that there is D2 in animals.There is no vitamin D2 in animals, only in some organisms of phytoplanton, invertebras, yeasts, and fungi like mushrooms. Vitamin D2 is not produced by land plants or vertebras, because they lack the precursor ergosterol.

You find only vitamin D3 in vertebrates. In animals, as human beeings, from eggs, fish and in animals that can live a natural live and be out in the sun. In other words, the animals we eat also get vitamin deficiency very easy.

Avatar of: TheSciAdmin

TheSciAdmin

Posts: 56

March 6, 2012

Thanks for pointing out this mistake. It has been fixed and a correction issued.

Thanks for reading!
~Jef Akst, editor, The Scientist

Avatar of: StanYoung

StanYoung

Posts: 3

March 6, 2012

The vast majority of the time that claims coming from observational studies are tested in randomized trials, the claims do not hold up. See Ioannidis, JAMA, 2005 and Young and Karr, Significance, 2011. The $32M might be better spent in an examination of the design and analysis strategies used in observational studies that makes them so unreliable.

Avatar of: EllenHunt

EllenHunt

Posts: 74

March 6, 2012

There are huge confounders staring the described study in the face that render it  virtually meaningless. (And I'm a critic of some vitamin use.)

1.) They are not monitoring vitamin-D levels in the study participants according to the article. If so, the study has little clue what vitamin D levels are for the participants. Nor do they know what EFA levels are for participants. They need to do that at least quarterly.

Why? Because unlike any drug trial, vitamin D is available from all kinds of sources, including sunlight. Just being in the study will make people more conscious about it. Some will just take the packets. Others will take the packets and decide to take a multi-vitamin. Some will take the packets and take cod liver oil.

Some participants will change their lifestyle because of being in the study and become more active, spending more time out in the sun. Etc.

The meaningful information is NOT intake of vitamin D. The meaningful information is ergocalciferol level. The study is measuring the WRONG THING. 

2.) Another very serious issue is what exactly is the content of the packets? These vitamin extracts are notoriously poorly characterized. I know of older studies that showed variations on the order of 800% or more in the vitamin content of a particular tablet. So what is the quality control on the supplement dosage?

Trust me. This is no small matter. A big problem with many vitamins in the USA is that what you read is NOT what you get. German and Swiss pharma sources have probably the best control of dose and contaminants. The USA just doesn't.

3.) What is the level of PCBs, mercury and other contaminants? It isn't possible to get fish derived oils today with no PCB content. The contaminants can have effect by themselves. When these are present, the study is no longer testing its hypothesis, it is testing contaminant supplementation too.

4.) What is the aldehyde level of the supplement? These oils oxidize on exposure to air. Rancid fats are mildly toxic. Depending on packaging, age, etc. rancidity will be higher.

Generally - Most studies buy from the cheapest source and in a long-term study that source will change from time to time to cut costs. Trust me, with fatty-acid supplements, the cheapest source is generally:
- The least reliable dosage.
- The most contaminated
- Has high levels of rancidity

Avatar of: EllenHunt

EllenHunt

Posts: 74

March 6, 2012

At the very least, the study should put a statistical sample of every batch of supplement of each type that is acquired through HPLC, record the fractions and do mass spec on the fractions. They will find surprises.

Avatar of:

Posts: 0

March 6, 2012


There is a mistake in the article. The no 2 picture tells that there is D2 in animals.There is no vitamin D2 in animals, only in some organisms of phytoplanton, invertebras, yeasts, and fungi like mushrooms. Vitamin D2 is not produced by land plants or vertebras, because they lack the precursor ergosterol.

You find only vitamin D3 in vertebrates. In animals, as human beeings, from eggs, fish and in animals that can live a natural live and be out in the sun. In other words, the animals we eat also get vitamin deficiency very easy.

Avatar of:

Posts: 0

March 6, 2012

Thanks for pointing out this mistake. It has been fixed and a correction issued.

Thanks for reading!
~Jef Akst, editor, The Scientist

Avatar of:

Posts: 0

March 6, 2012

The vast majority of the time that claims coming from observational studies are tested in randomized trials, the claims do not hold up. See Ioannidis, JAMA, 2005 and Young and Karr, Significance, 2011. The $32M might be better spent in an examination of the design and analysis strategies used in observational studies that makes them so unreliable.

Avatar of:

Posts: 0

March 6, 2012

There are huge confounders staring the described study in the face that render it  virtually meaningless. (And I'm a critic of some vitamin use.)

1.) They are not monitoring vitamin-D levels in the study participants according to the article. If so, the study has little clue what vitamin D levels are for the participants. Nor do they know what EFA levels are for participants. They need to do that at least quarterly.

Why? Because unlike any drug trial, vitamin D is available from all kinds of sources, including sunlight. Just being in the study will make people more conscious about it. Some will just take the packets. Others will take the packets and decide to take a multi-vitamin. Some will take the packets and take cod liver oil.

Some participants will change their lifestyle because of being in the study and become more active, spending more time out in the sun. Etc.

The meaningful information is NOT intake of vitamin D. The meaningful information is ergocalciferol level. The study is measuring the WRONG THING. 

2.) Another very serious issue is what exactly is the content of the packets? These vitamin extracts are notoriously poorly characterized. I know of older studies that showed variations on the order of 800% or more in the vitamin content of a particular tablet. So what is the quality control on the supplement dosage?

Trust me. This is no small matter. A big problem with many vitamins in the USA is that what you read is NOT what you get. German and Swiss pharma sources have probably the best control of dose and contaminants. The USA just doesn't.

3.) What is the level of PCBs, mercury and other contaminants? It isn't possible to get fish derived oils today with no PCB content. The contaminants can have effect by themselves. When these are present, the study is no longer testing its hypothesis, it is testing contaminant supplementation too.

4.) What is the aldehyde level of the supplement? These oils oxidize on exposure to air. Rancid fats are mildly toxic. Depending on packaging, age, etc. rancidity will be higher.

Generally - Most studies buy from the cheapest source and in a long-term study that source will change from time to time to cut costs. Trust me, with fatty-acid supplements, the cheapest source is generally:
- The least reliable dosage.
- The most contaminated
- Has high levels of rancidity

Avatar of:

Posts: 0

March 6, 2012

At the very least, the study should put a statistical sample of every batch of supplement of each type that is acquired through HPLC, record the fractions and do mass spec on the fractions. They will find surprises.

Avatar of:

Posts: 0

March 7, 2012

An important factor that is being ignored in these studies is the role of magnesium in all of this.  Due to agricultural practices our soil is being depleted of many minerals that are essential. Kidney stones, blocked arteries etc. can be caused by a lack of Mg in spite of having sufficient vitamin D. 

Trials with massive doses of D monthly etc. will not be valid if they are vitamin D2 as it does not have as long a lasting effect in the body as vitamin D3.

Avatar of:

Posts: 0

March 7, 2012

Vitamin D is the ‘newest trend’
most of my friends that  see traditional
doctors have been prescribed huge doses of vitamin D…I have reservations about
this issue…specially in southern states like where we live  in Texas where you have to go out of your way
not to be in the sunlight…no thanks, I will stick to the natural ways for optimum
vitamin D!

 

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Posts: 0

March 7, 2012

Vitamin D is the ‘newest trend’
most of my friends that  see traditional
doctors have been prescribed huge doses of vitamin D…I have reservations about
this issue…specially in southern states like where we live in Texas where you have to go out of your way
not to be in the sunlight…no thanks, I will stick to the natural ways for optimum
vitamin D!

 

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Posts: 0

March 7, 2012

You're smart!

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Posts: 0

March 7, 2012


Thanks, I have done my homework:-)

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silverlady3

Posts: 1

March 7, 2012

An important factor that is being ignored in these studies is the role of magnesium in all of this.  Due to agricultural practices our soil is being depleted of many minerals that are essential. Kidney stones, blocked arteries etc. can be caused by a lack of Mg in spite of having sufficient vitamin D. 

Trials with massive doses of D monthly etc. will not be valid if they are vitamin D2 as it does not have as long a lasting effect in the body as vitamin D3.

Avatar of: Maria

Maria

Posts: 1457

March 7, 2012

Vitamin D is the ‘newest trend’
most of my friends that  see traditional
doctors have been prescribed huge doses of vitamin D…I have reservations about
this issue…specially in southern states like where we live  in Texas where you have to go out of your way
not to be in the sunlight…no thanks, I will stick to the natural ways for optimum
vitamin D!

 

Avatar of: Maria

Maria

Posts: 1457

March 7, 2012

Vitamin D is the ‘newest trend’
most of my friends that  see traditional
doctors have been prescribed huge doses of vitamin D…I have reservations about
this issue…specially in southern states like where we live in Texas where you have to go out of your way
not to be in the sunlight…no thanks, I will stick to the natural ways for optimum
vitamin D!

 

March 7, 2012

You're smart!

Avatar of: Underpressure

Underpressure

Posts: 2

March 7, 2012


Thanks, I have done my homework:-)

Avatar of: jhnycmltly

jhnycmltly

Posts: 65

March 13, 2012

"most of my friends that  see traditional doctors have been prescribed huge doses of vitamin D"

Mine said to take calcium and vitamin D  and was obviously disappointed when I told him that I wasn't taking the advice.
Noone seems to be able to explain why removing iron by phlebotomy relieves vitamin D deficiency.
"The results reveal that the low serum 25-OHD concentration in patients with hemochromatosis is directly related to the extent of iron loading and it is improved by venesection therapy." 
"Evaluation of Growth, Puberty and Endocrine Dysfunctions in Relation to Iron Overload in Multi Transfused Indian Thalassemia Patients."
"92.8% had low levels of Vitamin D" 

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Posts: 0

March 13, 2012

"most of my friends that  see traditional doctors have been prescribed huge doses of vitamin D"

Mine said to take calcium and vitamin D  and was obviously disappointed when I told him that I wasn't taking the advice.
Noone seems to be able to explain why removing iron by phlebotomy relieves vitamin D deficiency.
"The results reveal that the low serum 25-OHD concentration in patients with hemochromatosis is directly related to the extent of iron loading and it is improved by venesection therapy." 
"Evaluation of Growth, Puberty and Endocrine Dysfunctions in Relation to Iron Overload in Multi Transfused Indian Thalassemia Patients."
"92.8% had low levels of Vitamin D" 

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March 14, 2012

 okay windows 7 so i just got a dell studios xps 13 and i always see those really cool windows 7 ultimate key commercials where you have 2 windows up and they spread it out where each one takes up half the screen. so how do you do it. windows 7 ultimate also i saw them have like 5 windows up and they would shake one of them and the rest would disapear then they would do it again and it would reappear . windows 7 key how do you do that . also how do i turn down and up the brightness on my keyboard.windows 7 ultimate product key if you know any other windows 7 tricks let me know to windows 7 product key andexplain how you do it thank you!

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Posts: 0

March 14, 2012

 okay windows 7 so i just got a dell studios xps 13 and i always see those really cool windows 7 ultimate key commercials where you have 2 windows up and they spread it out where each one takes up half the screen. so how do you do it. windows 7 ultimate also i saw them have like 5 windows up and they would shake one of them and the rest would disapear then they would do it again and it would reappear . windows 7 key how do you do that . also how do i turn down and up the brightness on my keyboard.windows 7 ultimate product key if you know any other windows 7 tricks let me know to windows 7 product key andexplain how you do it thank you!

Avatar of: huangke0530

huangke0530

Posts: 5

March 14, 2012

 okay windows 7 so i just got a dell studios xps 13 and i always see those really cool windows 7 ultimate key commercials where you have 2 windows up and they spread it out where each one takes up half the screen. so how do you do it. windows 7 ultimate also i saw them have like 5 windows up and they would shake one of them and the rest would disapear then they would do it again and it would reappear . windows 7 key how do you do that . also how do i turn down and up the brightness on my keyboard.windows 7 ultimate product key if you know any other windows 7 tricks let me know to windows 7 product key andexplain how you do it thank you!

Avatar of: huangke0530

huangke0530

Posts: 5

March 14, 2012

 okay windows 7 so i just got a dell studios xps 13 and i always see those really cool windows 7 ultimate key commercials where you have 2 windows up and they spread it out where each one takes up half the screen. so how do you do it. windows 7 ultimate also i saw them have like 5 windows up and they would shake one of them and the rest would disapear then they would do it again and it would reappear . windows 7 key how do you do that . also how do i turn down and up the brightness on my keyboard.windows 7 ultimate product key if you know any other windows 7 tricks let me know to windows 7 product key andexplain how you do it thank you!

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dpmsurf

Posts: 1

March 15, 2012

Vitamin d is good for you. The best way to get it is from the sun.  If you can't get enough that way try food high in Vitamin D.  If not try a supplement but you really need to trust the source of the vitamins.  To learn more about Vitamin D deficiency symptoms Click Here http://www.vitamin-d-deficienc...

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Posts: 0

March 15, 2012

Vitamin d is good for you. The best way to get it is from the sun.  If you can't get enough that way try food high in Vitamin D.  If not try a supplement but you really need to trust the source of the vitamins.  To learn more about Vitamin D deficiency symptoms Click Here http://www.vitamin-d-deficienc...

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Posts: 0

March 16, 2012

Ellen, Although I am not directly involved in research, my sister has worked in it, and she is, genuinely, one of the most honest individuals I've ever known.

More than once she terminated a research project on basis that the controls were violated.  Need I tell you this honesty on her part was treated by those she answered to as a career-advancement-killing character flaw?

Once, for example, when she was in charge of an intra-cellular study in burn victim monitoring, she discovered some students were falsifying that they were performing certain actions that they were omitting to perform.  She went to her superior, and M.D., and told him this, and he told her she was "over-reacting."

"Over-reacting!," she replied.  "These omissions of essential actions totally invalidated the results on the procedures and pharmaceuticals under study."

The superior threatened to have her removed, and she replied that if he did so she would provide an affidavit, citing names, dates and witnesses (yes, she had covered her posterior by including immaculately credible witnesses, because she knew from prior experience what the risks were).

She won the battle, but if promotions and recommendations can be described as "war," she lost the war.  She was sandbagged thereafter, and in evaluations was not cited for any violation of any procedure but, rather, was damned with faint praise, while others were praised far beyond their capacities or performance.  But Sis would have stood her ground again, a hundred times over.

If you knew her as I have known her all her life, you would not be surprised at this.

You know, and she knows, and I know... that there are at least some individuals in research who would rather die than lie about the data reported in connection with a scientific research project.  And no threat, no bribe, no promotion, no flattering evaluation would sway them one iota.  If it were NOT for those, like Sis, who believe in, and abide by, the principle that science is nothing, if not honest, then the results of all so-called scientific research would be a mockery of the very ideal called science, and would be a mockery of all would be so naive as to take the joke of it seriously.

To those who would sell their soul in science, and would call themselves "scientists," not only are they traitors to the very cause of science but, also, they take up space that could be allotted to someone honest.

Are there sell-outs?  Of course they are.  Some of them even gain managerial power and increased incomes and awards and acclaim.  They know who they are.  But, some may not care.

Because I have known one researcher who would not sell out, I am able to believe there is another, and another, and another...

Because I have known closely and well one individual who is everything a scientist can and should be, I am able to believe that science is an ideal that goes beyond the bounds of average human nature, but not an unreachable star.  It is a star some do, indeed, aspire to, and attain.

I cannot know it for a certainty, but I sense that you, too, are such a person as would not gloss over what -- if I were a crude person -- I might call half-fast research.

May you be heard, and understood, and appreciated for your stipulations on doing things correctly, or not calling them science.

( : > )    

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Posts: 0

March 16, 2012

 Test your levels. Then you will know if it is appropriate to supplement. Then test your levels again.

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Anonymous

March 16, 2012

Ellen, Although I am not directly involved in research, my sister has worked in it, and she is, genuinely, one of the most honest individuals I've ever known.

More than once she terminated a research project on basis that the controls were violated.  Need I tell you this honesty on her part was treated by those she answered to as a career-advancement-killing character flaw?

Once, for example, when she was in charge of an intra-cellular study in burn victim monitoring, she discovered some students were falsifying that they were performing certain actions that they were omitting to perform.  She went to her superior, and M.D., and told him this, and he told her she was "over-reacting."

"Over-reacting!," she replied.  "These omissions of essential actions totally invalidated the results on the procedures and pharmaceuticals under study."

The superior threatened to have her removed, and she replied that if he did so she would provide an affidavit, citing names, dates and witnesses (yes, she had covered her posterior by including immaculately credible witnesses, because she knew from prior experience what the risks were).

She won the battle, but if promotions and recommendations can be described as "war," she lost the war.  She was sandbagged thereafter, and in evaluations was not cited for any violation of any procedure but, rather, was damned with faint praise, while others were praised far beyond their capacities or performance.  But Sis would have stood her ground again, a hundred times over.

If you knew her as I have known her all her life, you would not be surprised at this.

You know, and she knows, and I know... that there are at least some individuals in research who would rather die than lie about the data reported in connection with a scientific research project.  And no threat, no bribe, no promotion, no flattering evaluation would sway them one iota.  If it were NOT for those, like Sis, who believe in, and abide by, the principle that science is nothing, if not honest, then the results of all so-called scientific research would be a mockery of the very ideal called science, and would be a mockery of all would be so naive as to take the joke of it seriously.

To those who would sell their soul in science, and would call themselves "scientists," not only are they traitors to the very cause of science but, also, they take up space that could be allotted to someone honest.

Are there sell-outs?  Of course they are.  Some of them even gain managerial power and increased incomes and awards and acclaim.  They know who they are.  But, some may not care.

Because I have known one researcher who would not sell out, I am able to believe there is another, and another, and another...

Because I have known closely and well one individual who is everything a scientist can and should be, I am able to believe that science is an ideal that goes beyond the bounds of average human nature, but not an unreachable star.  It is a star some do, indeed, aspire to, and attain.

I cannot know it for a certainty, but I sense that you, too, are such a person as would not gloss over what -- if I were a crude person -- I might call half-fast research.

May you be heard, and understood, and appreciated for your stipulations on doing things correctly, or not calling them science.

( : > )    

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Posts: 0

March 16, 2012

Yes, vitamins have interactions. And we know next to nothing about the variation in metabolism, breakdown, absorption, etc.

I think you have a very valid point. Unless levels of other vitamins, protein, lipid levels, blood sugar (are any diabetic? If so, what type?) exercise, illnesses (influenza like illness, colds, pneumonia, gastrointestinal diseases, cancers) and other factors are also recorded, you will miss a huge amount of information.

The more I think this study over, the more it seems to be designed in a way calculated to produce not just negative results, but false negative results. In fact, as I think about it, I find it hard to imagine a study with a worse design.

Bluntly, I think the studies are junk science, and a waste of time and money as it is conceived. If a student came to me with those designs in an oral examination, I would not vote to pass them.

For $32 million for the two studies described alone, I am pretty appalled at what is proposed here. I think the study design is so bad that NIH should pull the funding unless there is a rewrite of the protocol, data collection, etc. There is no reason for it to be this bad. That is plenty of money to do quarterly, or at least biannual blood draws and tests. That is plenty of money to do HPLC analysis of the supplement batches. Etc.

Avatar of: EllenHunt

EllenHunt

Posts: 74

March 16, 2012

 Test your levels. Then you will know if it is appropriate to supplement. Then test your levels again.

Avatar of: EllenHunt

EllenHunt

Posts: 74

March 16, 2012

Yes, vitamins have interactions. And we know next to nothing about the variation in metabolism, breakdown, absorption, etc.

I think you have a very valid point. Unless levels of other vitamins, protein, lipid levels, blood sugar (are any diabetic? If so, what type?) exercise, illnesses (influenza like illness, colds, pneumonia, gastrointestinal diseases, cancers) and other factors are also recorded, you will miss a huge amount of information.

The more I think this study over, the more it seems to be designed in a way calculated to produce not just negative results, but false negative results. In fact, as I think about it, I find it hard to imagine a study with a worse design.

Bluntly, I think the studies are junk science, and a waste of time and money as it is conceived. If a student came to me with those designs in an oral examination, I would not vote to pass them.

For $32 million for the two studies described alone, I am pretty appalled at what is proposed here. I think the study design is so bad that NIH should pull the funding unless there is a rewrite of the protocol, data collection, etc. There is no reason for it to be this bad. That is plenty of money to do quarterly, or at least biannual blood draws and tests. That is plenty of money to do HPLC analysis of the supplement batches. Etc.

Avatar of: Jim K

Jim K

Posts: 1

March 17, 2012

Clearly a great deal of this type of institutional fudging has gone on in the history of science and we (and science) are all the poorer for it.  

Leaving theory and the relationship between empirical research and theoretical models aside for the purpose of discussion here as they're simply complementary to my point, I was brought up to respect if not revere the essentials of the scientific method - and the notion that science doesn't set out to "prove" anything, rather to follow sound principles that either allow one to reject - or not reject within a stated range of confidence - a "null hypothesis" - and if the NH is rejected as a result of a carefully designed study, what's been learned is not that the hypothesis is "true," rather that it better fits the known (and now expanded) set of evidence, because the null hypothesis has been shown - at a known level of probability - to NOT fit in with what's now been observed and documented. 

This was deeply ingrained in me from high school on.

Most "anti-science" people don't get that research is basically a process of winnowing away possibilities that leaves those still standing approximations as the "most currently likely" to be useful models of how things in the universe work - until better approximations are found.  And so when follow-on studies further change models, the deniers say, "See! Science doesn't know anything.  They used to tell us that....[whatever] was true and now they say something else is."  So (they conclude) you "can't trust science."

But of course that turns the essence of scientific research on its head.  Scientific evidence is distinguished from belief by the very fact that, yes, research doesn't prove ANYTHING - but moves us all forward by disabusing us of notions (and models and theories) that have been found to be incorrect (or incapable of explaining all the known data).     

This is often not helped by the press which reports research or by the organizations sponsoring it or even by scientists out to make or cement their rep - often in competition with those promoting other hypotheses as "proof positive."  

And of course, scientists being human ARE often very emotionally invested in their theories and do seek confirmation of them (and sponsors often have significant public or private careers on the line and future profits or lack of same very much on their minds.)  And those in fact are several of the biases that the scientific method was invented to correct for.  

So for one matter, if the nature of scientific evidence were better explained to the public at large, the whole enterprise would be improved.  

Unfortunately, however, to what I think is an increasing extent, science is becoming less and less "scientific" on the whole and more openly "agenda-driven."  And not just by egotists wedded to hypotheses or companies pushing the near-term bottom line, but also due to the influence of governments, ideologies, local, national and global politics and more.  

I reckon (unscientifically) that a good portion of this derives from the fact that the scientific method began mostly in fields that are abstruse and removed from our own experience - in the (once) "hard sciences" like physics and chemistry which are (or were at the time) easier to be "objective" about.  

And that as science has progressed and turned its sights on things closer (and nearer and dearer) to us, we all feel we have more of a stake in the game, making it harder to maintain objectivity. (Especially as the objects of study become things about ourselves - our biology, health, longevity, psychology and sociology, e.g.)

Evolution - even more than Astronomy centuries earlier - seemed to many to pose a threat to the very basis of religious faith, by (seemingly) contradicting ancient and oft-translated texts laid down by technically unsophisticated peoples thousands of years ago, e.g., and while there are few "flat-earthers" around today, evolutionary science is very much still a political and social issue. 

(I've never seen the conflict between religion and science, btw - and while not religious, I'm happy to leave speculations and feelings about the "whys" to theology and philosophy - fields where I do find enduring value in arks of ethics - while leaving the "hows" of what goes on in the physical world to science, but I know I'm very likely in the minority on that.) 

And now ecological and nascent climatological studies challenge the basis of how far and fast human societies can go in exploiting the natural resources of the planet for profit, growth and convenience.  And seem to (and in current political practice) pit free-market capitalism against government planned societies (to over-simplify a multi-faceted gamut of forces in contention).  

These emerging sciences not only hit close to home - with implications for who should be in charge of what, and what rights individuals, corporations, governments and nations "should" have, but also carry the added freight of urgency as the validity of their models may (or may not) pose fairly immediate threats to our viability as a species and/or to life in general on the planet.  

With so much at stake (and so much research undone and given such immature theoretical models), the temptation and pressure to skew the "science" in ways wholly unscientific grows exponentially. 

In the current article which involves big pharma, nutritional science, "neutraceuticals," the FDA, NIH and other parties, much is at stake for people, clinicians, companies and public policy, e.g.

And more generally, while "Climategate" may not have undone the general consensus of scientific opinion about Climatology, it did (deservedly in my opinion) do damage to science's reputation in the public mind, even if it only brought out one example of what's gone on to one extent or another in some cases for centuries (e.g., hauling out the studies done by the "Tobacco Institute" back in the mid-20th century is a frequently cited example of "bad science"). 

But with the seas possibly about to inundate our coasts (or not), real disadvantages to any approach to meeting (and defining) our energy "needs," and important elections, treaties, industrial policies, gross domestic (and gross world) products, and supra-national politics all at stake I'm afraid we may be entering an age where there will be more and more telling "gates" to come. And science's best hope of maintaining its relevance and integrity is to do everything possible to police itself and make sure it stays true to the principles which have made it what it is (or still mostly is one hopes).

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Anonymous

March 17, 2012

To Jim K:  Enjoyed your thinking on these issues immensely.  One of the many questions I have striven with at the level of a personal philosophy are not merely the fundamental question of what knowledge is but, also, just how limited is the human brain's capacity "to know" -- no matter how much aided by technology to extend the probing of the human senses, nor how much aided by computerized quantification.  Without the capability of assuming, based upon inadequate sensory sampling, where the data samples are often fuzzy at best, we could not -- as we humans do -- cope so well with so little sampling and with almost no certainty about anything.  We walk in thought, as it were, by stepping from one stance of assumption to another to another...  And, given that overall situation, we nonetheless do quite well, it seems, at coping with the things we must cope with or perish sooner rather than later.

I suspect you have enjoyed, as I have, the input of Cuhn, Popper, Wittgenstein, Feyerabend and others in the so-called science wars between the realists and the post-modernists in the 90's.  What at once thrills me, intrigues me and intellectually satisfies me about those ideas is the deep down realization that if any of the intellectual positions could firmly ground itself on existential, objective certainties, it would have.  And until such existential objective certainties can be, and are, established, very little if anything can be argued without one's first laying down several unfalsifiable presumptions to apply logical operations to.

Add to that dilemma the notion of superposition (in the sense that the location or vector of a thing, or the relative meaning of one thing from a point of observation in a foreign frame of reference as regarding one thing, may be determined only pursuant to another coming later in time, just as, for example, the fate of Shroedinger's cat may not be determined in respect to such time as the box has been opened, whereupon the cat's condition is determined, or locked in, upon such opening of the box).  Hence, it is not without precedence in seriously argued classical or quantum physics, to posit the superposition of the existence of God, such that he exists for the mind that believes and does not exist for the mind which does not.  If this seems absurd, then it is not one iota less absurd than is the prospect (for which there is at least much circumstantial empirical evidence by proxy) on part of some of the most brilliant theoretical physicists.  To further compound the contemplation of such a dilemma, there is a possibility that if there co-exist both one set of "rules" at one scale of matter and energy (classical level) and a different set of "rules" at another (quantum) then we have abundant precedent to ask, then, why might not there be a tertiary set of "rules" at some other scale, and still others at other scales.    

Thence for anyone to deem it "scientific" to posit God's existence, on grounds the positor has no empirical evidence to thus violate Occam's presumption that it is wrong to add complexity to uncertainty, then it is no less absurd to posit the non-existence of God, for the same rule... insofar as empirical science is rational.  Either of these two positings introduces a subsumptive relation to the contemplation of empirical grounding and hence adds complexity.  BUT, in view of the fact that the vast preponderance of human coping relies upon assumptive stances galore, it is not in the least contrary to the use of the human brain to take either of two currently and locally unascertainable superpositings into, as it were, one's cope-consideration field.  

I do not mean, however, to fail to harp on this one aspect of your open-minded thoughts on the contemplation of what is good science.  You and I would concur, I take your attitude to be, that if one were conducting a research project and were asked to count the peas in a pod and find six of them there, and we were to report that we had counted and found fifteen, then we would thereby have misreported in a way we would be, as a scientist, under an ethical duty and obligation to report as we found it.  Too bad our empirical findings are not always so clearly defined and quantifiable as the number of peas in a given pod.  Too bad, to boot, that there is no empirical evidence that the ethics of being ethical can be tested empirically.  After all, if a thief steals a horse, gets away with it, enjoys all the benefits of horse-ownership thence forth, and those facts become known to a scientist and verified by him or her, and the scientist is unable to trace the prior owner/possessor of the horse, to confirm that he gave a darn, does not the "known" evidence constrain a valuing of non-ethical behavior in that instance?

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Posts: 0

March 17, 2012

Clearly a great deal of this type of institutional fudging has gone on in the history of science and we (and science) are all the poorer for it.  

Leaving theory and the relationship between empirical research and theoretical models aside for the purpose of discussion here as they're simply complementary to my point, I was brought up to respect if not revere the essentials of the scientific method - and the notion that science doesn't set out to "prove" anything, rather to follow sound principles that either allow one to reject - or not reject within a stated range of confidence - a "null hypothesis" - and if the NH is rejected as a result of a carefully designed study, what's been learned is not that the hypothesis is "true," rather that it better fits the known (and now expanded) set of evidence, because the null hypothesis has been shown - at a known level of probability - to NOT fit in with what's now been observed and documented. 

This was deeply ingrained in me from high school on.

Most "anti-science" people don't get that research is basically a process of winnowing away possibilities that leaves those still standing approximations as the "most currently likely" to be useful models of how things in the universe work - until better approximations are found.  And so when follow-on studies further change models, the deniers say, "See! Science doesn't know anything.  They used to tell us that....[whatever] was true and now they say something else is."  So (they conclude) you "can't trust science."

But of course that turns the essence of scientific research on its head.  Scientific evidence is distinguished from belief by the very fact that, yes, research doesn't prove ANYTHING - but moves us all forward by disabusing us of notions (and models and theories) that have been found to be incorrect (or incapable of explaining all the known data).     

This is often not helped by the press which reports research or by the organizations sponsoring it or even by scientists out to make or cement their rep - often in competition with those promoting other hypotheses as "proof positive."  

And of course, scientists being human ARE often very emotionally invested in their theories and do seek confirmation of them (and sponsors often have significant public or private careers on the line and future profits or lack of same very much on their minds.)  And those in fact are several of the biases that the scientific method was invented to correct for.  

So for one matter, if the nature of scientific evidence were better explained to the public at large, the whole enterprise would be improved.  

Unfortunately, however, to what I think is an increasing extent, science is becoming less and less "scientific" on the whole and more openly "agenda-driven."  And not just by egotists wedded to hypotheses or companies pushing the near-term bottom line, but also due to the influence of governments, ideologies, local, national and global politics and more.  

I reckon (unscientifically) that a good portion of this derives from the fact that the scientific method began mostly in fields that are abstruse and removed from our own experience - in the (once) "hard sciences" like physics and chemistry which are (or were at the time) easier to be "objective" about.  

And that as science has progressed and turned its sights on things closer (and nearer and dearer) to us, we all feel we have more of a stake in the game, making it harder to maintain objectivity. (Especially as the objects of study become things about ourselves - our biology, health, longevity, psychology and sociology, e.g.)

Evolution - even more than Astronomy centuries earlier - seemed to many to pose a threat to the very basis of religious faith, by (seemingly) contradicting ancient and oft-translated texts laid down by technically unsophisticated peoples thousands of years ago, e.g., and while there are few "flat-earthers" around today, evolutionary science is very much still a political and social issue. 

(I've never seen the conflict between religion and science, btw - and while not religious, I'm happy to leave speculations and feelings about the "whys" to theology and philosophy - fields where I do find enduring value in arks of ethics - while leaving the "hows" of what goes on in the physical world to science, but I know I'm very likely in the minority on that.) 

And now ecological and nascent climatological studies challenge the basis of how far and fast human societies can go in exploiting the natural resources of the planet for profit, growth and convenience.  And seem to (and in current political practice) pit free-market capitalism against government planned societies (to over-simplify a multi-faceted gamut of forces in contention).  

These emerging sciences not only hit close to home - with implications for who should be in charge of what, and what rights individuals, corporations, governments and nations "should" have, but also carry the added freight of urgency as the validity of their models may (or may not) pose fairly immediate threats to our viability as a species and/or to life in general on the planet.  

With so much at stake (and so much research undone and given such immature theoretical models), the temptation and pressure to skew the "science" in ways wholly unscientific grows exponentially. 

In the current article which involves big pharma, nutritional science, "neutraceuticals," the FDA, NIH and other parties, much is at stake for people, clinicians, companies and public policy, e.g.

And more generally, while "Climategate" may not have undone the general consensus of scientific opinion about Climatology, it did (deservedly in my opinion) do damage to science's reputation in the public mind, even if it only brought out one example of what's gone on to one extent or another in some cases for centuries (e.g., hauling out the studies done by the "Tobacco Institute" back in the mid-20th century is a frequently cited example of "bad science"). 

But with the seas possibly about to inundate our coasts (or not), real disadvantages to any approach to meeting (and defining) our energy "needs," and important elections, treaties, industrial policies, gross domestic (and gross world) products, and supra-national politics all at stake I'm afraid we may be entering an age where there will be more and more telling "gates" to come. And science's best hope of maintaining its relevance and integrity is to do everything possible to police itself and make sure it stays true to the principles which have made it what it is (or still mostly is one hopes).

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March 17, 2012

To Jim K:  Enjoyed your thinking on these issues immensely.  One of the many questions I have striven with at the level of a personal philosophy are not merely the fundamental question of what knowledge is but, also, just how limited is the human brain's capacity "to know" -- no matter how much aided by technology to extend the probing of the human senses, nor how much aided by computerized quantification.  Without the capability of assuming, based upon inadequate sensory sampling, where the data samples are often fuzzy at best, we could not -- as we humans do -- cope so well with so little sampling and with almost no certainty about anything.  We walk in thought, as it were, by stepping from one stance of assumption to another to another...  And, given that overall situation, we nonetheless do quite well, it seems, at coping with the things we must cope with or perish sooner rather than later.

I suspect you have enjoyed, as I have, the input of Cuhn, Popper, Wittgenstein, Feyerabend and others in the so-called science wars between the realists and the post-modernists in the 90's.  What at once thrills me, intrigues me and intellectually satisfies me about those ideas is the deep down realization that if any of the intellectual positions could firmly ground itself on existential, objective certainties, it would have.  And until such existential objective certainties can be, and are, established, very little if anything can be argued without one's first laying down several unfalsifiable presumptions to apply logical operations to.

Add to that dilemma the notion of superposition (in the sense that the location or vector of a thing, or the relative meaning of one thing from a point of observation in a foreign frame of reference as regarding one thing, may be determined only pursuant to another coming later in time, just as, for example, the fate of Shroedinger's cat may not be determined in respect to such time as the box has been opened, whereupon the cat's condition is determined, or locked in, upon such opening of the box).  Hence, it is not without precedence in seriously argued classical or quantum physics, to posit the superposition of the existence of God, such that he exists for the mind that believes and does not exist for the mind which does not.  If this seems absurd, then it is not one iota less absurd than is the prospect (for which there is at least much circumstantial empirical evidence by proxy) on part of some of the most brilliant theoretical physicists.  To further compound the contemplation of such a dilemma, there is a possibility that if there co-exist both one set of "rules" at one scale of matter and energy (classical level) and a different set of "rules" at another (quantum) then we have abundant precedent to ask, then, why might not there be a tertiary set of "rules" at some other scale, and still others at other scales.    

Thence for anyone to deem it "scientific" to posit God's existence, on grounds the positor has no empirical evidence to thus violate Occam's presumption that it is wrong to add complexity to uncertainty, then it is no less absurd to posit the non-existence of God, for the same rule... insofar as empirical science is rational.  Either of these two positings introduces a subsumptive relation to the contemplation of empirical grounding and hence adds complexity.  BUT, in view of the fact that the vast preponderance of human coping relies upon assumptive stances galore, it is not in the least contrary to the use of the human brain to take either of two currently and locally unascertainable superpositings into, as it were, one's cope-consideration field.  

I do not mean, however, to fail to harp on this one aspect of your open-minded thoughts on the contemplation of what is good science.  You and I would concur, I take your attitude to be, that if one were conducting a research project and were asked to count the peas in a pod and find six of them there, and we were to report that we had counted and found fifteen, then we would thereby have misreported in a way we would be, as a scientist, under an ethical duty and obligation to report as we found it.  Too bad our empirical findings are not always so clearly defined and quantifiable as the number of peas in a given pod.  Too bad, to boot, that there is no empirical evidence that the ethics of being ethical can be tested empirically.  After all, if a thief steals a horse, gets away with it, enjoys all the benefits of horse-ownership thence forth, and those facts become known to a scientist and verified by him or her, and the scientist is unable to trace the prior owner/possessor of the horse, to confirm that he gave a darn, does not the "known" evidence constrain a valuing of non-ethical behavior in that instance?

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March 21, 2012

No mention of the risk of Vitamin D supplementation in hyperparathyroidism, which can greatly increase the risk of stroke if high doses are given to those with undiagnosed parathyroid adenomas. Lowering Vitamin D is the body's way of responding to high blood calcium according to Dr. James Norman, who specializes in the treatment of parathyroid tumors.

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March 21, 2012

Eating is a very primitive activity.  It is practically impossible to be rational about it.  I'm convinced that is why nutritional findings are all over the map and why the field is so trendy.  There is just an enormous amount of superstition out there, from vitamins to GMO foods, and we professionals are not immune to it. 

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Cheryl Soehl

Posts: 2

March 21, 2012

No mention of the risk of Vitamin D supplementation in hyperparathyroidism, which can greatly increase the risk of stroke if high doses are given to those with undiagnosed parathyroid adenomas. Lowering Vitamin D is the body's way of responding to high blood calcium according to Dr. James Norman, who specializes in the treatment of parathyroid tumors.

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mightythor

Posts: 1457

March 21, 2012

Eating is a very primitive activity.  It is practically impossible to be rational about it.  I'm convinced that is why nutritional findings are all over the map and why the field is so trendy.  There is just an enormous amount of superstition out there, from vitamins to GMO foods, and we professionals are not immune to it. 

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Posts: 0

March 22, 2012

I just couldn't resist responding to this, however delayed I may be.
Although it is good to bring up the idea that environmental variation can impact a study, these studies (should have? did have?) control groups built in that should experience the same or similar environments to the treatment groups.
With respect to all these horrible chemicals in the water, please note that dose matters - as does practicality. Chloroform, for example, is highly volatile and evaporates very quickly - I highly doubt that the tiny amount of choloroform detected in Los Angeles' water actually stays in the water until it's gone all the way to your tap and your water glass. Similarly, your body has ways of dealing with/sequestering and secreting low levels of otherwise toxic chemicals. That is because these chemicals always have been present at low levels in our environment. The small amount of chromium, or arsenic, or chromium (again), is captured as it is absorbed, bound to other elements or compounds your body stores for just such exposures, and secreted before it can accumulate and cause you harm.

But perhaps bringing up concerns about chemicals in water is really just to encourage you to buy fancy water.

And finally, GMOs. I don't really understand how one can conclude that GMOs lack important vitamins or minerals. What would the purpose of this be? Modifying organisms (mostly plants) is done with the goal of increasing hardiness, or reistance to other environmental influences such as pests and weeds, as well as pesticides and herbicides. The modifications (usually adding a resistance gene, or modifying an existing gene to strengthen resistance) have no impact on the overall chemical composition of the organism - or at least, certainly not to the extent that its nutritional value is impacted. I have never heard of Theobald Smith (which means nothing), but isn't it more likely that the issue is merely that cattle are being fed corn instead of being allowed to graze, and that genetically modified corn (or not) has absolutely nothing to do with whatever his conclusions are?

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Sannica

Posts: 1

March 22, 2012

I just couldn't resist responding to this, however delayed I may be.
Although it is good to bring up the idea that environmental variation can impact a study, these studies (should have? did have?) control groups built in that should experience the same or similar environments to the treatment groups.
With respect to all these horrible chemicals in the water, please note that dose matters - as does practicality. Chloroform, for example, is highly volatile and evaporates very quickly - I highly doubt that the tiny amount of choloroform detected in Los Angeles' water actually stays in the water until it's gone all the way to your tap and your water glass. Similarly, your body has ways of dealing with/sequestering and secreting low levels of otherwise toxic chemicals. That is because these chemicals always have been present at low levels in our environment. The small amount of chromium, or arsenic, or chromium (again), is captured as it is absorbed, bound to other elements or compounds your body stores for just such exposures, and secreted before it can accumulate and cause you harm.

But perhaps bringing up concerns about chemicals in water is really just to encourage you to buy fancy water.

And finally, GMOs. I don't really understand how one can conclude that GMOs lack important vitamins or minerals. What would the purpose of this be? Modifying organisms (mostly plants) is done with the goal of increasing hardiness, or reistance to other environmental influences such as pests and weeds, as well as pesticides and herbicides. The modifications (usually adding a resistance gene, or modifying an existing gene to strengthen resistance) have no impact on the overall chemical composition of the organism - or at least, certainly not to the extent that its nutritional value is impacted. I have never heard of Theobald Smith (which means nothing), but isn't it more likely that the issue is merely that cattle are being fed corn instead of being allowed to graze, and that genetically modified corn (or not) has absolutely nothing to do with whatever his conclusions are?

Avatar of: JustAskAlice

JustAskAlice

Posts: 5

March 27, 2012

I won't hold my breath. Why focus on one (or two) chemicals when overall health seems to be the primary objective? What makes vitamin D uniquely important? It amazes me how much effort is made toward understanding just one (or two) chemical(s) when they cannot be isolated and tracked in an experiment. Garbage in, garbage out. In my opinion, the philosophy of distilling nature down to a specific pharmacology is not appropriate in this context. Why? Because "overall health" is the primary objective and not the prevention of a specific disease caused by a specific molecular manifestation (eg. breast cancer driven by HER2 amplification). My guess is that a holistic approach would be more useful. In this case, design a trial to compare a balanced but strictly vegetarian (or vegan) diet versus a typical American one. Through simple but smart questionnaires, I bet you would find a more profound, and meaningful, answer. You may not find the "silver bullet" chemical but you may find the "silver bullet" behavior. I'm not going to hold my breath for this one either.

Avatar of: JustAskAlice

JustAskAlice

Posts: 5

March 27, 2012

I commend the researchers for taking on an unpopular task. However, I won't hold my breath. There appear to be too many confounding factors in order to accurately isolate a cause-effect relationship. I'd like to take a step back and ask the following: What makes vitamin D uniquely important? It amazes me how much effort is made toward understanding just one (or two) chemical(s) when they cannot be isolated and tracked in an experiment. In my opinion, the philosophy of distilling nature down to a specific pharmacology is not appropriate in this context. Why? Because "overall health" is the primary objective and not the prevention of a specific disease caused by a specific molecular manifestation (eg. breast cancer driven by HER2 amplification). My guess is that a holistic approach would be more useful. In this case, design a trial to compare a balanced but strictly vegetarian (or vegan) diet versus a typical American one. The evidence is equally (or more) compelling than vitamins D in isolation. Through simple but smart questionnaires, I bet you would find a more profound, and meaningful, answer. You may not find the single magical chemical but you may find the better behavior (for both individual and society). I'm not going to hold my breath for this one either.

Avatar of:

Posts: 0

March 27, 2012

I won't hold my breath. Why focus on one (or two) chemicals when overall health seems to be the primary objective? What makes vitamin D uniquely important? It amazes me how much effort is made toward understanding just one (or two) chemical(s) when they cannot be isolated and tracked in an experiment. Garbage in, garbage out. In my opinion, the philosophy of distilling nature down to a specific pharmacology is not appropriate in this context. Why? Because "overall health" is the primary objective and not the prevention of a specific disease caused by a specific molecular manifestation (eg. breast cancer driven by HER2 amplification). My guess is that a holistic approach would be more useful. In this case, design a trial to compare a balanced but strictly vegetarian (or vegan) diet versus a typical American one. Through simple but smart questionnaires, I bet you would find a more profound, and meaningful, answer. You may not find the "silver bullet" chemical but you may find the "silver bullet" behavior. I'm not going to hold my breath for this one either.

Avatar of:

Posts: 0

March 27, 2012

I commend the researchers for taking on an unpopular task. However, I won't hold my breath. There appear to be too many confounding factors in order to accurately isolate a cause-effect relationship. I'd like to take a step back and ask the following: What makes vitamin D uniquely important? It amazes me how much effort is made toward understanding just one (or two) chemical(s) when they cannot be isolated and tracked in an experiment. In my opinion, the philosophy of distilling nature down to a specific pharmacology is not appropriate in this context. Why? Because "overall health" is the primary objective and not the prevention of a specific disease caused by a specific molecular manifestation (eg. breast cancer driven by HER2 amplification). My guess is that a holistic approach would be more useful. In this case, design a trial to compare a balanced but strictly vegetarian (or vegan) diet versus a typical American one. The evidence is equally (or more) compelling than vitamins D in isolation. Through simple but smart questionnaires, I bet you would find a more profound, and meaningful, answer. You may not find the single magical chemical but you may find the better behavior (for both individual and society). I'm not going to hold my breath for this one either.

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