ANH-USA to File Health Claim for Vitamin D—and It’s All Thanks to You! (Plus a Vitamin D Update)January 18, 2011
In addition to this exciting announcement, we have some troubling news to report: more conflicts of interest over the Institute of Medicine’s vitamin D report, and more evidence from a top Harvard expert that the IOM recommendations fly in the face of good science. What is really going on here?
First, the good news: Represented by famed attorney Jonathan Emord, the Alliance for Natural Health USA will be filing a Qualified Health Claim Petition with the FDA for vitamin D.
For many years, the US Food and Drug Administration held that health claims for foods or substances could only be made if there was Significant Scientific Agreement (SSA) about the claim. This is a standard which is almost impossible to reach in science.
Under pressure of court losses, the Agency finally relented. Its 2003 Consumer Health Information for Better Nutrition Initiative acknowledged that consumers benefit from more information on food labels concerning diet and health. As part of this initiative, the agency established interim procedures whereby “qualified” health claims can be made with a lower standard of scientific evidence, so long as the claims do not mislead consumers. These “qualified” health claims are often initiated by a petitioner—in this case, us.
It means that if the FDA accepts our petition, producers and sellers of vitamin D will be able to make certain specific claims about its ability to treat certain diseases or conditions.
We want to make it abundantly clear that we are able to file this petition only because of the generous financial support of our members. YOU are making things happen in a big way—and improving the lives of countless Americans. Thank you!
At the same time, we need to update you on the Institute of Medicine’s vitamin D report—the one that recommended such ridiculously low daily vitamin D allowances for most people. Dr. Walter Willett, one of the scientists who reviewed the IOM report but whose comments were never made public by the IOM (nor were the comments of any of the other reviewers), has published a summary of his concerns regarding vitamin D, calcium, and bone health. According to Dr. Willett, the randomized controlled trials (RCTs) studied by the IOM show that the daily dosage of vitamin D they recommended is too low to prevent the risk of bone fractures.
Please keep in mind that Dr. Willett, who teaches at Harvard, is probably the most famous nutritional scientist in the world. His comments will not be easily dismissed by the leaders of the Institute of Medicine. The IOM’s report was based almost solely on the effect of vitamin D on bone health; other health benefits were largely ignored. Now Dr. Willett says they didn’t even get the bone science right.
Before proceeding further, a quick chemistry lesson. Whether it is made in the skin or ingested, vitamin D3 (also called cholecalciferol) passes through the liver and becomes 25-hydroxycholecalciferol; this is usually abbreviated 25(OH)D. The level of 25(OH)D is measured in nanomoles per liter, or nmol/l.
Dr. Willett says that the IOM report suggestion that 50 nmol/l is sufficient is plainly contradicted by the IOM’s own data. The RCTs proved that the 50 nmol/l threshold “was insufficient for fracture or fall reduction.” By contrast, the International Osteoporosis Foundation’s analysis recommended a threshold of 75 nmol/l for optimal fall and fracture reduction, and recommended 800 to 1,000 IU of vitamin D per day for seniors age 60 years and older. And beyond the RCTs, there is compelling evidence that higher 25(OH)D blood serum levels can be effective in fighting colorectal cancer.
Tellingly, in their press conference about the IOM report, the authors admitted that the group initially chose 10,000 IU a day as an acceptable upper limit for vitamin D, then decided to reduce this to 4000 IU at the last moment—giving no indication why they made such a sudden and dramatic reversal, especially considering their own data contradicted those recommendations.
As we reported last month, one of the authors of the report, Dr. Glenville Jones—the one who openly pooh-poohed the idea that most people are vitamin D deficient—is an advisor for Cytochroma, a pharmaceutical company developing a synthetic drug version of vitamin D. Now we learn that he is also on the board of another drug company, Receptor Therapeutics, which has in the pipeline a drug called Onco-D102—an intravenous, high-dose vitamin D drug for the treatment of cancer. The drug is still in the preclinical stage. Could this obvious conflict of interest have anything to do with IOM’s recommendations which fly in the face of science?
Dr. Willett also reports that the IOM’s “safe upper limit” for calcium appears too high. He says that data supporting recommended calcium levels and bone health, especially in regard to hip bone density and fracture risk, is insufficient. There is also recent data on the possible adverse effects of calcium supplements on cardiovascular health and kidney stones—and with appropriate vitamin D supplementation, calcium recommendations should be adjusted downwards.
Regular Pulse readers already know that supplemental calcium should never be taken alone. It needs additional magnesium, vitamin D, omega–3 fatty acids, and vitamin K (in particular, vitamin K-2, which is especially important). Without these essential co-factors, the calcium may end up in our blood vessels or our heart, where it causes harm, rather than our bones, where it is needed. So long as these co-factors are taken as well, many studies have shown that added calcium plays an important role in building and maintaining bone mass—and also reduces the risk of colon cancer. Studies showing vitamin D’s effect on viruses such as the flu are less extensive but also persuasive. As we noted in an earlier article, one Japanese study found vitamin D much more effective at preventing the flu than vaccines.
The problem is, the government (not to mention the media) blindly accepts the IOM’s recommendations. And that blindness can be lethal—especially when government agencies have to come back later and say, “Whoops! We goofed!” The RDA for vitamin D has now been significantly raised, but it’s nowhere near as high as the science shows we need. The government recommends calcium, but still has no idea that it is dangerous without the necessary co-factors.