It seems like it never ends...FYI Link to article and a link to click on to sign a petition-- http://www.anh-usa.org/action-alert-is-the-institute-of-medicine-in-bed-with-big-pharma/ December 7, 2010 As we reported last week, the Institute of Medicine’s (IOM) new and absurdly low vitamin D recommendation flies in the face of scientific evidence. Now we need your help to get Congress to launch an investigation. Some may ask, “Why are you treating this report as such a big deal? I’ll take however many vitamins I wish, and the government has no say in the matter.” But unless these findings are challenged, the public will accept it as true. Doctors, medical institutions, the media, and governmental agencies will all parrot these ultra-low recommendations on vitamin D dosage, pooh-poohing its important therapeutic benefits, and keeping the American public dangerously deficient in the vitamin. This will mean more colds, more flu, greater dependence on dangerous flu shots and antibiotics, more illness in general, more weak bones, more cancer, and many more deaths. Some experts calculate that proper vitamin D supplementation could save Americans $4.4 trillion over a decade—about $1,346 per person every year. The IOM updated its official vitamin D recommendations for the first time since 1997. Despite raising the new vitamin levels by 300% for most Americans (suggesting that their previous vitamin D level recommendation was off by 300%), the IOM guidelines are still in contrast to overwhelming scientific evidence that confirms the significant medical benefits of higher vitamin D levels. A recent Harvard Medical School study and numerous other research institutes and doctors have found that vitamin D supplementation is safe and effective, and recommend significantly higher levels than the Institute of Medicine. The IOM now recommends 600 IU (international units) for people between the ages of 1 and 70—their previous recommendation was a mere 200 IU—whereas Harvard and the Vitamin D Council recommend anywhere from 1,000 to 5,000 IU a day. Studies also show that least one-third of Americans are wholly deficient in vitamin D (and a University of Tennessee Health Science Center study says 87% of patients are mildly to severely deficient). This is due to changing lifestyle and cultural trends in which many people in the US get less sun exposure and often inadequate dietary levels of the vitamin. A simple blood test will confirm whether one is deficient or not, although the IOM now appears to want to change the standard for optimum blood serum levels so that a lower level will still get a passing grade. (The IOM suggests the new standard should be changed to 20 ng/ml, whereas previously anything under 30 ng/ml was considered deficient. The Vitamin D Council recommends between 50 and 80 ng/ml.) The IOM is supposed to be an independent voice. This “quasi-public” non-profit NGO (non-governmental organization) was founded in 1970 under the congressional charter of the National Academy of Sciences. Its purpose is to provide national advice on issues relating to biomedical science, medicine, and health, and its mission is to serve as advisor to the nation to improve health. It works outside the framework of the federal government to provide independent guidance and analysis, and it is supposed to operate under a rigorous, formal peer-review system. The problem is, the study carried out by the IOM Food and Nutrition Board violated sound scientific process, and its report, Dietary Reference Intakes for Calcium and Vitamin D, fails to meet the evidentiary standard. For one thing, the researchers 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 so-called 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 a bundle of money from it, so no one will shell out the millions of dollars necessary for a decent randomized controlled trial. It’s the proverbial Catch-22. We might also add that the so-called drug gold standard doesn’t even fit dietary supplements. Supplements, which are concentrated food, must always be evaluated in the context of the rest of the diet. In the case of bone health, for example, vitamin D should be taken with calcium, vitamin K (especially K2), and other elements. These are vital co-factors and need to be present together. Supplemental calcium should not be taken without supplemental magnesium (although magnesium may be taken without calcium). And so forth. None of these essential nutrients is a synthetic drug and none of them should be evaluated in the same way as dangerous, synthetic drugs. On top of that, the types of studies the IOM considered were arbitrarily selected and all over the map. For example, in looking at cancer generally, 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 (their new, ultra-low, laboratory blood test level recommendations are the bare minimums for the prevention of bone disease), 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 the upper limits of vitamin D dosage, the IOM reversed course completely. Here they used not random controlled trials but only observational studies and animal studies because of “ethical considerations”—though since they weren’t performing the studies themselves, one could hardly accuse them of overdosing their subjects. The upshot is that the evidentiary bar was substantially lowered in determining potential harm. They decided the upper limit should be 4,000 IU, even though many experts say 5,000 is a good daily dose, with higher amounts to correct imbalances—and even the majority of studies the IOM considered say that toxicity doesn’t occur until somewhere between 25,000 and 40,000 IU per day. But, as they put it, “In the absence of a benefit at higher levels [as shown by RCTs], the cautious approach was deemed justified.” Please note that this conflates safety and efficacy in a typical example of circular reasoning. Even though the available evidence suggests that it is safe to take higher doses, it isn’t really safe because the benefits have not been demonstrated to the researchers’ satisfaction, using criteria that cannot possibly produce a positive result. To put all this in context, 600 IU (the new recommended daily dose) is equal to just four minutes of mid-day full-body summer sun exposure. About thirty minutes of sunshine would produce approximately 4,000 to 5,000 IU of natural vitamin D in many American latitudes, which the new guidelines indicate may be an overdose. If this is true, nature seems to have goofed badly. The Vitamin D Council reports that the Food and Nutrition Board (FNB) consulted with fifteen vitamin D experts (whom they thank on page vii of their report) and, after reading these fifteen different reports, the FNB decided to suppress them. “Many of these consultants are either famous vitamin D researchers, like Prof. Robert Heaney at Creighton University or, as in the case of Prof. Walter Willett at Harvard, the single best-known nutritionist in the world. So why won’t the FNB tell us what Professors Heaney and Willett thought of their new report?” The Vitamin D Council has filed a federal Freedom of Information (FOI) request to the IOM’s FNB for the release of these fifteen reports. The Vitamin D Council also points out out that the new recommendation says that an infant and a 300-pound pregnant woman should have the same daily intake, which shows how totally absurd this recommendation really is. There is, unfortunately, a hidden agenda afoot. A pharmaceutical company is developing a patentable man-made vitamin D analog—yes, a synthetic drug version of vitamin D. And Glenville Jones, PhD, one of the committee members who determined the new vitamin D guidelines and who is quoted as saying that under these guidelines, 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,” is an advisor for that same pharmaceutical company. While the IOM presents itself as a private entity, eighty percent of its budget comes from federal grants. The General Accountability Office (GAO) has a statutory authority to improve the performance and ensure the accountability of groups using tax dollars for the benefit of the American people. The IOM report was sponsored by multiple government agencies and administrations, which means the report and the IOM itself can be subject to investigation by the GAO. In addition, the GAO has previously investigated the IOM and their public health reports. So beginning today, ANH-USA is collecting signatures for a petition which we will send to Congress. We will be asking Congress to do two things: Appoint a new scientific panel to look at all the vitamin D data, including the research from Harvard, the Vitamin D Council, and the fifteen reviewers whose research was suppressed by the FNB. The panel needs to look at all the studies, whether they were Randomized Controlled Trials or not, to see if there is a correlation between vitamin D and health benefits other than bone health, and specifically review whether it was appropriate to lower target serum levels based on limited evidence related to bone health alone. They also need to investigate how the IOM selected upper limits even while admitting there was a lack of evidence to support their findings. Ask the GAO to investigate the IOM’s behavior in the creation of this report. The GAO needs to find out why the opinions of the fifteen vitamin D experts were suppressed, and examine the relationship between the scientist on the IOM panel and the pharmaceutical company for whom he is a consultant. They also need to investigate the IOM’s Office of News and Public Information and its role in the widely divergent and inaccurate 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%. Please sign our petition! We must get Congress to review this latest example of flawed science and crony capitalism. Please take action today!