Volume 14 • Number 9 • September 2013

EDITOR’S NOTE

I hope you have been following the GMO[1] issue (see my blogs.) Despite the Food Industry’s and Monsanto’s efforts to discredit anyone who opposes them as purveyors of pseudoscience, the public still smells a rat. Connecticut just passed a law requiring the labeling of food containing GMOs. Whether GMOs are toxic or not, we have the right to choose. That Monsanto wrote the recently passed bill HR933, passed by the politicians it also bought, does not reassure me. HR933 states that Monsanto cannot be sued in the future if we solidly establish GMOs toxicity. Below you will find studies suggesting the food industry cares more for their profits than our health. I know, knock me over with a feather.

Hugo Rodier, MD

 

Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe Out of Balance.[2]

“Between 1997 and 2012, every notice U.S. regulators received to vouch for the safety of common food additives was submitted by someone with a vested interest in the outcome of those assessments, according to a study published in JAMA Internal Medicine on Wednesday. The analysis found that all of the 451 notifications voluntarily submitted to the Food and Drug Administration (FDA) during that time were made by people who had relationships with manufacturers of food additives. “If the company makes the decisions or picks the people, there are a lot of possibilities for undue influence,” said Thomas Neltner, the study’s lead author from The Pew Charitable Trusts in Washington, D.C.

Under current practices, companies are allowed to decide whether or not their food additives are “generally recognized as safe,” or GRAS, and only voluntarily tell the agency about their decisions. “If they never tell the agency, there’s a chance for harm,” Neltner, director of Pew’s food additives project, added. In a previous study, Neltner and his colleagues estimated that about 43% of the 10,000 or so additives allowed in food were on the FDA’s GRAS list, with other additives approved through other means or not submitted to the FDA. Manufacturers made their own safety determinations for about 1,000 additives without ever notifying the agency.

When a manufacturer submits a notice to the FDA, the agency responds with a letter that affirms the GRAS determination or one that says the notice didn’t provide enough evidence for the decision. In response to concerns raised by members of Congress about the program, the Government Accountability Office (GAO), a federal watchdog agency, issued a report in 2010. It found multiple instances of the FDA prohibiting additives previously recognized as GRAS. The GAO found the “FDA’s oversight process does not help ensure the safety of all new GRAS determinations.” “What we wanted to do is see if that was true. So we looked at where the light was the best. We looked at the 451 notices that were submitted (to the FDA) for review,” Neltner said.

Of the safety assessments, about 22% were made by an employee of the food additive manufacturer and about 13% by employees of manufacturer-hired consulting firms. Another 64% were submitted by expert panels whose members were picked by either manufacturers or consulting firms. None of the expert panels, which included an average of four people, were selected by third parties, write the researchers. Also,Neltner and his colleagues found that 10 experts served on 27 or more panels. One was a member of 128 panels, about 44% of the total.

In a statement to Reuters Health, the Grocery Manufacturers Association, a trade organization, said GRAS determination is an important part of the FDA’s current regulatory framework and that it is “a very thorough and comprehensive process.” “We also recognize that the GRAS process, like any other, can be improved. That is why we are committed to working with the FDA and other stakeholders to identify ways of strengthening the GRAS review process so that it can continue to help ensure the safety of our food supply, just as it has done for decades,” it continued.

The FDA said in a statement to Reuters Health that it encourages companies to submit their GRAS determinations, because it is a way to ensure the decisions are based on “sound data and information.” “For example, the addition of caffeine to a widening array of products like chewing gum, waffles, and syrup is an example of where notification of a company’s GRAS determination would have been useful for both government and industry,” said the statement. The FDA added that it plans to issue guidance to industry on meeting the GRAS criteria. According to the GAO, the GRAS notification program still operates under an interim status, because the last change to the process in 1997 was never finalized.

“The good news is that once the FDA gets the documentation, it does its job and encourages manufacturers of questionably safe additives to withdraw their notices. But then what happens? Who knows,” Dr. Marion Nestle, a professor of nutrition, food studies and public health at New York University, told Reuters Health in an email. “We need a better food safety system in this country and the conflicts of interests in (GRAS) additive approvals are a good place to start,” Dr. Nestle, who wrote an editorial accompanying the study, added.

Neltner and his colleagues recommend that the GRAS program minimize conflicts of interest by modeling policies off of the rules set for other panels, including drug advisory committees. They also write that the FDA should require that it be notified of all GRAS determinations and conflicts of interest, then release that information to the public. “Right now the safety of the food is dependent on the integrity and competency of the company (that people) are buying their food from. The more they know about the company making the food they’re buying, the more reliable it will be,” Neltnersaid.”

Still getting popped?”

It’s hard to quit any addiction, particularly when one is not aware that one is addicted. If you are still drinking soda pop despite all the studies pointing out its addictive and toxic nature, at least continue to read about this problem. Perhaps in the future you will decide to stop hurting yourself. In kids it is a big reason for their weight gain[3] and their behavioral problems.[4] I suspect it is the same in adults. We do know that it artificial sweeteners in pop disrupt brain signaling[5] so that you do not feel satisfied, nor particularly strong-willed, and thus keep drinking it, which is good for Coca Cola, not you, nor your pocketbook.

First do no financial harm.”

Primo non nocere:” Doctors swear upon graduating that we will do no harm. It would be good to expand the concept of harm to financial issues.[6]Doctors have a duty to avoid financial stress in their patients; too many unnecessary tests and treatments have financial side effects, too. Most filings for bankruptcy are due to devastating health care bills. Is the Affordable Care Act (Obama Care) an answer? I say no for reasons not dissimilar to that of giving a starving child stale bread. I know, pretty dramatic, but hear me out: It is now generally admitted that our present Health Care Delivery system is broken;[7] we waste $750+ billion per year, ~30% of the total money spent each year in health care in the USA.[8] Yet, we rank dead last in the industrialized world, where the healthiest nations spend half of what the USA does.[9]

Many feel this sad state of affairs is due to the present system focusing on only 10% of the factors that affect our health, leaving 90% of them unattended: “Health Care delivery accounts for only 10% of preventable deaths, with the remainder attributable to personal behaviors, social and environmental determinants, and genetic predispositions. As currently constituted the Health care delivery system has little direct control over these other factors.”[10]

We will (?) be heaping more financial stress on our already sick economy by buying into such a wasteful and unproductive system. Who does the Affordable Care Act really benefit? Chew on this: Mr. Obama got more financial contributions for his 2007 Presidential campaign than Mr. McCain; this was the first time ever that Big Pharma supported a Democrat over a Republican. oh, and bankers did, too.[11]

Telegraphed articles

“Relying on NPs and PAs Does Not Avoid the Need for Policy Solutions for Primary Care.”[12] Why not? Half of them also specialize.

“Consumption of a Diet Low in Advanced Glycation Endproducts for 4 weeks Improves Insulin Sensitivity in Overweight Women.”[13] Cooking at lower temperatures helps lose weight. Raw food probably better, but most people cannot eat that way.

“How low can you go? Blood pressure and mortality in chronic kidney disease.”[14] If your kidneys get a filtration number (EGFR) <60, you need to back off treatment to see if that is the cause.

“Association of gestational maternal hypothyroxinemia and increased autism risk.”[15] Low thyroid, yet, another factor in this complex disease.

Sufficient sleep duration contributes to lower cardiovascular disease risk in addition to four traditional lifestyle factors: the MORGEN study.”[16]Best: at least 7 hours.

Mediterranean diet and glycaemic load in relation to incidence of type 2 diabetes: results from the Greek cohort of the population-based European Prospective Investigation into Cancer and Nutrition (EPIC).”[17] Best diet: a combination of the two listed.

“Association of coffee consumption with all-cause and cardiovascular disease mortality.”[18] More than 4 servings a day decreases longevity. Don’t reach diminishing returns.

“Use of Antihypertensive Medications and Breast Cancer Risk Among Women Aged 55 to 74 Years.”[19] Calcium Channel Blockers frohypertension are now implicated.

 

[1] Genetically Modified Organisms: pesticides injected into the DNA of crops.

[2] JAMA Intern Medicine 2013;():-. doi:10.1001/jamainternmed.2013.10559. Reuters Health, August 07 2013

[3] “Sugar-Sweetened Beverages and Weight Gain in 2- to 5-Year-Old Children,
J. Pediatrics 2013-0570; Published online August 5, 2013 (10.1542/peds.2013-0570)

[4] “Soft soda drinks are associated with behavioral problems in 5 year-olds,” J. of Pediatrics Epub August 16th 2013

[5] “Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements,”
J. Trends in Endocrinology and MetabolismEpubJuly 10 2013 http://download.cell.com/images/edimages/Trends/EndoMetabolism/tem_888.pdf

[6] “First do no financial harm,” JAMA 2013;310;577

[7]Crossing the Quality Chasm,” Institute of Health Press, 2001

[8] Institute of Medicine September 6, 2012

[9] “The US Health Disadvantage Relative to Other High-Income Countries,”
Journal of the American Medical Association 2013;309:771

[10] “Bridging the divide between health and health care,”
Journal of the American Medical Association 2013;309:1121

[11] http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aRCVqfSQ43Eo

[12] J. American Family Physician 2013;88(4):230

[13] J. Diabetes Care Published online before print August 19, 2013, doi: 10.2337/dc13-0842

[14] J. Annals of Internal Medicine 2013; 159: 302

[15] J. Annals of Neurology Epub August 13 2013

[16] J. European Journal of Preventive Cardiology Epub July 3, 2013, doi: 10.1177/2047487313493057

[17] J. Diabetologia Epub August 16 2013

[18] J. Mayo Clinic Proceedings 2013; DOI:10.1016/j.mayocp.2013.06.020

[19] JAMA Intern Medicine 2013 Epub August 5, 2013

Hugo Rodier, MD is an integrative physician based in Draper, Utah who specializes in healing chronic disease at the cellular level by blending proper nutrition, lifestyle changes, & allopathic practices when necessary.

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