In a recent meta-analysis published in the British Medical Journal (BMJ), Roth et al accurately wrote that randomized controlled trials (RCTs) of vitamin D to help prevent the diseases of pregnancy have shown mixed results. The authors give a number of reasons that may explain the negative trials, notably inadequate dose. Additionally, as any competent scientist would, Dr. Roth et al opine that until RCTs show efficacy without toxicity, higher doses of vitamin D should not be used in pregnancy. That is, they say Evidence Based Medicine requires physicians to continue recommending the 400 – 800 IU (10 – 20 mcg/day) of vitamin D during preganacy, the amount contained in most prenatal vitamins.
However, if their standard were followed, physicians would not treat scurvy with vitamin C, beriberi with thiamine, pellagra with niacin or prevent neural tube defects with folic acid. Indeed, wouldn’t Roth et al recommend the vitamin D be taken out of current prenatal vitamins, as no RCTs proved usefulness before its addition. To the best of my knowledge, physicians of the past addressed the pathological consequences of the inadequate intake of nutrients, not with more science and RCTs, but with observation, weighing potential benefits with potential risks and a healthy dose of common sense. Indeed, do you think smoking causes lung cancer? If so, please point me to the controlled human clinical trial that shows it does.
Take autism as an example. Five studies, totalling 518,270 subjects, unanimously reported low levels of vitamin D during pregnancy are associated with a substantially increased risk (RR up to 4.0) of developing autism in offspring.[i], [ii], [iii], [iv], [v] However, Dr. Roth and other scientists argue science will not know, and tell physicians not to use, high doses of vitamin D to help prevent autism until RCTs prove it safely does so.
However, two crucial points are missed with such an opinion. The first is that vitamin D is safe. If you think vitamin D is dangerous at physiological adult doses (125-250 mcg/day or 5,000-10,000 IU/day), you are simply ignorant about its toxicology.
As Paracelsus stated:
“All things are poison, and nothing is without poison; the dose alone makes a thing poison.” As early as 1999, Reinhold Vieth convincingly demonstrated that 50,000 (1.25 mg)/day is probably vitamin D’s safe upper limit (no deaths), not 10,000 IU/day.
Poison Control recently reported from 2000-2014 there were 14,397 reports in the US on overdoses of vitamin D. There were only 3 cases of hypercalcemia, but no deaths resulted from any of these 14,000 overdoses. In comparison, there were at least 3,000 deaths due to Tylenol overdose during that same period.
Finally, there are stark differences between scientists and physicians. With the onset of Evidence Based Medicine, physicians have steadily let science, an altogether different discipline, dictate our practice. Scientists, using the scientific method, require definitive proof before a theorem is considered scientific fact; in other words, beyond a reasonable doubt. But scientists do not treat patients, with a few notable exceptions. Instead scientists pursue the truth.
Physicians do no such thing and have never done it. Although it sounds sacrilegious at first, we do not use the scientific method to practice medicine and never have. We use trial and error. Good medicine bases its trials on science, the more frequently those trials result in failure, the further we have to get away from science. Unless, that is, we simply tell the sick patient that there is nothing we can do for him when we run out of scientifically proven treatments. While the good practice of medicine is based on science, it is a practice, like farming, and is hardly the practice of science.
Scientists do not take the Hippocratic Oath, while physicians do, or some derivative of it. Does our Oath not hold we are sworn to prevent disease; nowhere does it say we support dozens of additional studies before acting when evidence already exists showing a benign supplement may help prevent multiple horrendous diseases from occurring. Where are our ethics?
Physicians have never required such absolute proof until very recently, with the onset and misunderstanding of Evidence Based Medicine. As the oft quoted Sackett et al wrote, “Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external scientific evidence from systematic research.” [vi] Note the emphasis on “best available evidence.”
What for example, is the “best available evidence” published to date on vitamin D during pregnancy and prevention of autism? As detailed above, five studies exist and all five show the prevalence of autism in offspring increase as vitamin D levels during pregnancy decrease. But that, the scientists accurately say, is not the same as saying vitamin D supplements given during pregnancy will help prevent autism.
But that argument ignores the “best available evidence” dictum. Certainly, the best available evidence indicates higher levels of vitamin D during pregnancy will help prevent autism, without telling us how to obtain higher 25(OH)D levels during pregnancy. But isn’t that simply common sense? Paralyzing us into doing nothing as the autism rate grows is simply an example of how science is telling physicians how to practice medicine.
Instead, physicians have always, until recently, weighed the potential consequences of action vs. the potential harm of inaction, that is the potential benefit vs. potential harm. If you weigh in on the potential harm side, the call for more studies side, you are reading a different vitamin D literature (now at 61,323 plus peer reviewed publications) than me.
Physicians are required by law and ethics to act on evidence known today, not on what may be discovered tomorrow. If we continue to allow science’s war on medicine, what will we say to the parents of the children with autism?
John Cannell, MD. Science’s War on Medicine. The Vitamin D Council Blog & Newsletter, January 26, 2018.