Subject: New RDA findings contrary to scientific evidence about vitamin D in IOM Food and Nutrition Board report, and other concerns

Dear [Decision Maker],

On November 30, the Institute of Medicine's Food and Nutrition Board released its report Dietary Reference Intakes for Calcium and Vitamin D. While the board raised its Recommended Daily Allowance for vitamin D by 300%, these new levels are still far below the levels recommended by most scientific research, including studies from Harvard University, the Vitamin D Council, and the most noted nutritional experts in the world.

Our concern is that the FNB panel failed to meet the evidentiary standard in their review, in that they refused to consider much of the evidence on vitamin D -- their findings are based solely on the relationship between vitamin D and bone health, excluding all other health outcomes, citing a paucity of Randomized Controlled Trial (RCT) evidence. They stated that only RCTs can show a causal relationship between an intervention (like vitamin D) and an outcome (like cancer).

In other words, the IOM is holding a vitamin to the pharmaceutical gold standard. There's a reason there are few RCTs for vitamin D: it's not a patentable substance, so no big pharmaceutical company stands to make money from it, so no one will invest the millions of dollars necessary for a decent randomized controlled trial. More to the point, such an approach doesn't even befit dietary supplements, because they are essentially concentrated foods that must always be evaluated in context with the rest of one's diet.

The board appears to have cherry-picked the studies they reviewed. For example, in looking at vitamin D and cancer, only four studies were reviewed -- and none used vitamin D in doses higher than 1000 IU per day, far below the therapeutic dose, so of course they found no relationship between vitamin D and cancer control. Further, because the IOM declared that vitamin D benefits only bone health, they never suggested optimum levels for overall health. Why didn't they look at vitamin D levels in the healthiest of people before stating that vitamin D serves only one purpose?

In determining toxicity and the upper limits of vitamin D dosage, the IOM reversed course completely. Here they did not use RCTs, but only observational studies and animal studies, and for reasons they themselves cannot adequately explain, they decided the upper limit should be 4,000 IU (lower than the Vitamin D Council's recommended daily dose of 5,000 IU) even though the majority of studies the IOM considered say that toxicity doesn't occur until somewhere between 25,000 and 40,000 IU per day.

So we, the undersigned, are petitioning Congress to appoint a new scientific panel, one that looks at all the available vitamin D data, including studies that did not benefit from RCTs. The FNB received reports from fifteen respected experts in the field, but the board did not consider their findings, and did not publish their reports. We would like a new scientific panel to take the research of these experts seriously and publish their findings.

Such a panel should investigate any correlation between vitamin D and health benefits (other than bone health, the only correlation noted in the report), and should review whether it was appropriate to lower the target serum levels based on limited evidence related to bone health alone. We would also ask the scientific panel to investigate how the IOM selected upper limits even while admitting there was a lack of evidence to support their findings.

In addition to the new scientific panel, we are petitioning you to have the Government Accountability Office investigate the IOM's behavior in the creation of this report. While the IOM presents itself as a private entity, eighty percent of its budget comes from federal grants. The GAO has statutory authority to ensure the accountability of those using tax dollars for the benefit of the American people.

We would have the GAO ask: Why were the opinions of the fifteen vitamin D experts suppressed?

And what is the relationship between Glenville Jones, PhD, one of the FNB committee members who determined the new vitamin D guidelines, and Cytochroma, Inc., the pharmaceutical company for whom he is a scientific advisor, which is developing a patentable synthetic vitamin D analog -- essentially a drug version of vitamin D (in fact, the motto on their website is "Promoting Health through Vitamin D Therapeutics"). When the report was released, Dr. Jones was quoted as saying that most people "probably don't have vitamin D deficiency" and "We think there has been an exaggeration of the public's interest in vitamin D deficiency" -- inappropriate statements for a board member with such a prominent conflict of interest.

We believe the GAO also needs to investigate the IOM's Office of News and Public Information and its role in the widely divergent and harshly slanted media coverage of the IOM report, in which many news outlets seemed to think the report was warning us about the dangers of vitamin D when in fact the FNB had raised the recommended daily allowance by 300%.