Rolaids Recall Adds To Indigestion

When McNeil Consumer Healthcare recalled its product Rolaids the other day, it reminded consumers of a disturbing Big Pharma practice. From the press release (bold-facing is our own):

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews (full product details below) distributed in the United States.  McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

Morals of the story: Maybe reconsider that double cheeseburger in the first place, never assume Big Brand quality control, and "multi-symptom plus anti-gas softchew"? Wethinks the focus group for this consumer product was not focused on raw-food enthusiasts.

Opinion: Vitamin D Panel Misses the Mark on Deficiency

By Woodson Merrell, M.D.

The IOM report on calcium and vitamin D questioned what’s accepted as state-of-the-art thinking on what constitutes a vitamin D deficiency. This is a key point because the amount of vitamin D a person takes above and beyond the new Daily Recommended Intake of 600 international units should be based on whether they have a measurable deficiency or not, which is determined by how much of the vitamin is stored in their body. [D is stored mainly in fat cells, and most accurately established by measuring circulating blood levels of 25-hydroxyvitamin D or 25(OH)D.] The new IOM report sets the “normal” range for 25 (OH) D at 20-30 nanograms/milliliter, back to levels that were established when the test was first developed 3 decades ago. But I will not adapt this new recommendation.25-hydroxyvitamin D: Doctors must measure 25 (OH) D levels in the blood to establish a deficiency.

When scientists first set the normal D range thirty years ago, they lacked accurate tools for gauging a deficiency, and so they rather simplistically measured 25 (OH) D levels of people who had no symptoms of deficiency, using those levels to set the bar for what was considered healthy. Now, we have the capability of looking at functional biomarkers (biochemical indicators that the vitamin is doing its job) such as parathyroid hormone, calcium absorption, and bone mineral density. Based on voluminous research  spearheaded by one of the world’s leading experts, Bruce Hollis PhD, scientists have more accurately defined vitamin D deficiency as circulating 25 (OH) D levels of less than 32 nanograms. That’s what I look for when I counsel my patients on D supplements. 

The amount of D a person takes beyond the new minimum of 600 international units (and maximum of 4,000) is best  determined by the blood test--not by guesswork. In my opinion, the IOM panel, while correct in tripling the minimum daily dose and doubling the maximum safe dose, has missed the mark in determining what constitutes a deficiency that necessitates additional vitamin D supplementation. 

Vitamin D Hatchet Job

Here we go again. New York Times reporter Gina Kolata--who has written articles critical of mammograms, food allergy testing, and even the humble exercise cool-down--has another ax to grind, this time against vitamin D. She's so eager to debunk that her article in yesterday's paper makes it tough to even make sense of the report by a prestigious Institute of Medicine panel convened to make new recommendations on Vitamin D and calcium intake. The Times headline alone, "Report Questions Need for 2 Diet Supplements," does little to convey the contents of the panel's 999 page report.Gina Kolata

In fact, the panel concluded the U.S. should triple recommended daily intake of Vitamin D from 200 to 600 international units daily, and double what's considered a safe upper limit of intake from 2,000 to 4,000 international units daily for maintaining optimum health in people ages 9 to 70 years old. A major take-away from the report (produced by a committee of 13 physician professors at major university medical centers including Harvard, Yale, Baylor, Penn State, Cornell and University of California at San Diego) is that before taking more than the recommended amount of vitamin D, people should be tested for a deficiency of the vitamin, which is fat soluble and can accumulate to levels that adversely effect health if taken by someone without a deficiency. 

The IOM press release states the new recommendations (to take at least 600 and no more than 4000 international units of vitamin D per day) are "based on much more information and higher-quality studies than were available when the values for these nutrients were first set in 1997." We repeat: the new report recommends increasing the Daily Recommended Intake (DRI) of vitamin D, and it contains a warning about the very real dangers of taking high-dose vitamin D without an established deficiency. But Kolata manages to turn it into a broad indictment of D.

The new report leaves room for debate about D--how much is enough (the new range of 600-4000 international units  leaves ample room for interpretation); and what constitutes a deficiency (the new report says blood levels below 20 nanograms/milliliter are too low, but many experts who've studied the issue feel 32 nanograms is optimal for bone and other health.) But when you get into the body of Kolata's story, you won't find any of the substantial arguments clearly articulated. You will, however, learn plenty about how much vitamin D and calcium is sold in the U.S., and how the market for those supplements has grown. This seems to bother Kolata a lot. While helping people avoid unnecessary expenditures on supplements is a worthy journalistic goal, consumers seeking optimal health want to learn about the latest scientific advances in order to make informed purchasing decisions. Kolata's story adds confusion to the panel's announcement, and gives scant information about the science behind the new recommendations. 

A few examples of the tepid (at best) evidence presented by Kolata in support of her dark thesis: "To assess the amounts of vitamin D and calcium people are getting, the panel looked an national data on diets. Most people, they concluded get enough calcium from the foods they eat."  So now we are to believe the American diet provides adequate calcium and vitamin D? We would have liked contarian Kolata to ask the IOM committee members she interviewed to site some evidence  from their voluminous report to support that claim. If she did, she didn't bother to put it in her story.

On Vitamin D intake, Kolata had this to say: "In general, most people are not getting enough vitamin D from their diet, but they have enough of the vitamin in their blood, probably because they are also making it naturally after being out in the sun and storing it in their bodies." We're sorry, but seeing as how this is a front page article debunking one of the hottest areas of medical research in one of the most important newspapers on the planet, we would hope for a bit more scientific back-up than this. Since when is "probably" a definitive word in science? Here's what the National Institute of Health has to say on the subject:

"The energy from the sun is not enough for the skin to make vitamin D during the coldest months in the northern half of the United States—above a line drawn between Boston and the northern border of California. Cloudy days, shade, and having dark-colored skin also cut down on the amount of vitamin D the skin makes.

People who avoid the sun, who cover their bodies with sunscreen or clothing, or who live in the northern half of the United States during the winter months should include good sources of vitamin D in their diets or take a supplement. Recommended intakes of vitamin D are set on the assumption of little sun exposure."

On how much Vitamin D is enough, Kolata wrote, "The committee concluded a level of 20-30 25(OH)D nanograms is all that is needed for bone health, and nearly everyone is in that range." This is a statement in direct contradiction to conclusions by researchers, including Holick and the National Institute of Health, who have been studying vitamin D metabolism for a decade, and say 32 is the minimum amount of circulating vitamin 25 ()H) D required for maintaining health. It would be important to ask the panel what evidence they are basing this recommendation on, but Kolata offers no such substantiation. We can only assume she didn't ask the question. 

And on why more doctors have begun to recommend vitamin D testing and supplementation over the past 5 years, Kolata wrote this: "It's not clear how or why the claims for high vitamin D levels start, medical experts say." We'd like to know who the medical experts are that she refers to here--and make sure to avoid their pronouncements in the future. Anyone who's not comatose in the world of medical science knows the spotlight was shed on vitamin D deficiency by the world renowned expert Michael Holick, a biochemist and endocrinologist at Boston University who has spent a career researching the effects of vitamin D--which is actually not a vitamin but a hormone precursor. Not calling Dr. Holick for a quote in this article is an omission rather like forgetting to call the State Department for a quote on the Wikileaks scandal. 

Kolata went to the trouble to get market data on vitamin D sales, which is a specious, even insinuating reporting tactic. Companies make money selling insulin for diabetes and chemotherapy to treat cancer too, but those drugs' profitability doesn't automatically cast suspicion on them. We would expect less innuendo and more hard reporting from The New York Times, but we have to admit we've come not to expect that from Gina Kolata.

Yes of course we need more research into the biological mechanisms of vitamin D, and all of the vitamins for that matter. And yes, it's never a good idea to take mega-doses of any substance based on the logic that more-is-better. And yes it's important to establish through an accurate blood test that an individual has a deficiency before recommending supplementation above the DRI (Daily Recommended Intake.) Furthermore, I agree with the report, which found no advantage, and perhaps even harm, in taking high levels of calcium.  Vitamins and minerals are not the magic bullets many people would like them to be, nor are they the scourge of a health-crazed nation. We are constantly learning more about the value and power of all of the essential nutrients--they are not to be trifled with, but neither should they be dismissed.

In terms of making headlines, let's strive to accurately report what we do know, and resist the temptation to swing wildly from sensationalizing a nutrient to tearing it down, leaving consumers confused and even frightened in the aftermath of a media frenzy. 

Click here to read a National Institute of Health report on the current state of vitamin D research. 

Yoga vs Walking

Yoga is probably the most heavily studied wellness practice, and now a study out of Boston University and Harvard (among other participating centers) brings the evidence to a new level. The latest research measures levels of the key brain neurotransmitter, GABA (gamma-aminobutyric acid), before and after yoga sessions, and compares it to GABA levels wrought by a program of brisk walking.

Reduced activity in the brain's GABA systems is a hallmark of a number of mood disorders, anxiety disorders and epilepsy; and treatment with pharmacological agents that increase GABA is known to improve those conditions. Because there is a large body of research on the beneficial effects of exercise on depression and anxiety, researchers decided to make GABA a study target.

In a preliminary study using magnetic resonance spectroscopy, the researchers demonstrated that experienced yoga practitioners had a significant (27%) increase in GABA levels after a 60-minute session of yoga postures compared to no change in GABA levels in controls after a 60-minute reading session. This raised the question of whether the associated increase in GABA leves was specific to yoga or related to physical activity in general.

In order to find out, researchers recruited 34 healthy 18-45 year olds not taking psychoactive medications and followed them for 12 weeks of three 60-minute sessions per week of either Iyengar yoga or walking. What they found is that yoga beat walking for improving mood and anxiety measured by standardized psychological tests, but the increase in GABA levels was about the same for yoga and walking.

The researchers commented that yoga has been shown in previous studies to increase activity in the parasympathetic nervous system--the body's built-in system for reversing the stress response--which sends signals to return heart beat, breath rate and blood pressure (among other systems) to normal, non-stressed operating levels after a stressful event. There might also be something to be said here for the placebo effect. Everyone knows yoga is supposed to make you calm and happy, and sometimes knowing it can help makes it so.

To Reap the Benefits of Fish Oil, Take the Right One and Take it Early

This week's study in the Journal of the American Medical Association finding fish oil capsules did not prevent Alzheimers is a classic case of a narrow conclusion upon which the media is making broad sweeping generalizations. In the study, people were given pills containing the Omega 3 Fatty Acid DHA (decosahexaenoic acid), which is only one of a group of omega oils that can reduce inflammation and have the potential to help prevent inflammatory conditions such as Alzheimer's. The negative results of the JAMA study run counter to previous research, and one reason might be the study used the wrong pill.Look for darker-hued fish oil capsules, in which the manufacturing process has not destroyed beneficial properties of the oil.

So-called "whole omega" fish oil supplements (which were not used in this most recent study) contain the Omega 3, 5, 6, 7 and 9's, which are the oils found in wild-caught salmon. It is thought the balance of Omega 3 to Omega 6 fatty acids is more important for preventing inflammation than the presence of Omega 3 fatty acids alone. The manufacturing process is also key, it has to be a low-heat process similar to that used in making Extra Virgin Olive Oil, which preserves the natural oil as well as the powerful antioxidant, Astaxanthin, found in wild-caught fish oil. While more research is clearly needed to sort all of this out, this recent study is by no means definitive.

In addition to the researcher's curious choice of a fish oil product that contains only one type of omega fatty acid, the researchers also set the pill a very difficult task by choosing participants already diagnosed with Alzheimer's. Fish oil has not been touted as a cure for Alzheimer's, but rather as a preventive strategy. In order to test fish oil's powers of prevention, a study would have to include only people who had no diagnosis of Alzheimer's, and follow the development of Alzheimer's over time. An ideal group would be people with a family history of Alzheimer's who have not developed symptoms.

So before you throw away your fish oil, check to be sure that it is a whole omega product and not DHA alone... and take it early, at middle age, before inflammation takes its toll on the ol' grey matter.