February 2014 – “More on What We Put in Our Bodies”

Published in the Westchester Guardian, February 2014

A Summary of Items in Our ‘Medications’

My last column (January 30th, 2014) focused on the quality of specific foods placed in our bodies when eating out. Now, I look at our medications.

From sensitivity to religious beliefs to toxicity in our medications, there are issues with what is placed inside the drugs we place inside our bodies. My Obsessive Compulsive Disorder has led me to this topic. (Maybe a little bit of good can come out of mental illness). I am insecure about the power the profit motive may have on this industry combined with the cultural trend that smaller government is better government, (thereby reducing oversight) and the use of foreign manufacturing facilities.

Background. To make medications function properly there are certain ingredients added other than the active component needed to keep us healthy. These items in our medications, vitamins and supplements are called excipients. Wikipedia defines them as: inactive substances formulated alongside the active ingredients of medications, with various objectives from bulking-up formulations to therapeutic-enhancing purposes, such as facilitating drug absorption. The choice of excipients depends on factors such as the manufacturing process, route, dosage form and the active ingredient. Some of the various names and types are: binders, coatings, fillers, flavors, colors, lubricants, preservatives and sweeteners.

“Pharmaceutical regulations and standards require that all ingredients in drugs, as well as their chemical decomposition products, be identified and shown to be safe. As with new drug substances and dosage forms thereof, novel excipients themselves can be patented; sometimes, however, a particular formulation involving them is kept as a trade secret instead (if not easily reverse-engineered).”

Generic Drugs. Scientific American. Nov 12, 2009, by Molly Webster. “A generic drug contains the same active ingredient, which provides therapeutic benefit, as does brand-name versions. But having the same medicinal component doesn’t mean the two pharmaceuticals are identical. They may contain different inactive ingredients, for pill coatings and color or to bind the constituents into tablet form.”

The U.S. Food and Drug Administration has posted staff in certain regions (including China, India, Europe, and Latin America) for oversight of imported, processed, medical products. What are the details of these inspections? Who monitors the monitors?

Problem, Vegetable or Animal. British Medical Journal, Feb 4, 2014, summarized:

• Most medications prescribed in primary care contain animal derived products. It’s unclear whether they’re suitable for vegetarians.
• Labelling of animal content is poor and variably instituted.
• Patients with specific dietary restrictions are likely to be consuming animal products unwittingly.    

The website, The Examiner, February 23, 2013, via the British Medical Journal: Quoted the authors: “We already know that doctors are fairly ignorant about the issue of excipients in medication”.  “Vegetarians and those on restricted diets unwittingly eating animal gelatin in meds.” “Clearer content labeling, the adoption of a vegetarian symbol as is done for foodstuffs, and changes in the manufacturing process could all help patients make informed choices as well as promoting best practice in medical care, they suggest.”

Problem, Supplements. The New York Times, Health, November 3, 2013, by Anahad O’Connor. An estimated $5 billion a year industry on unproven herbal supplements.

• Of 44 herbal supplements tested, one-third showed outright substitution, meaning there was no trace of the plant advertised on the bottle.
• Many were adulterated with ingredients not listed on the label, like rice, soybean and wheat, which are used as fillers.
• “The regulations are very appropriate and rigorous,” said Duffy MacKay, Council for Responsible Nutrition, a supplement industry trade group. “But we need a strong regulator enforcing the full force of the law. F.D.A. resources are limited, and therefore enforcement has not historically been as rigorous as it could be.”
• “Unfortunately, we are seeing a very high percentage — approximately 70 percent — of firms’ noncompliance,” Shelly Burgess, FDA spokeswoman.

Problem, Red dye. Various web sites report: Allura Red AC, a red azo dye going by several names including: Allura Red, Food Red 17, Red 40. Originally manufactured from coal tar, is now mostly made from petroleum. It has fewer health risks compared to other azo dyes. Some studies have found some adverse health effects. In Europe, it’s not recommended for consumption by children. It’s banned in Denmark, Belgium, France, Switzerland. Also banned in Sweden until the country joined the European Union.The European Union approves Allura Red AC as a food colorant, but EU countries’ local laws banning food colorants are preserved.

In the United States, Allura Red AC is approved by the Food and Drug Administration for use in cosmetics, drugs and food such as soft drinks, children’s medications, and cotton candy. It’s the most commonly used red dye in the U.S. In June 2010, the Center for Science in the Public Interest called for the FDA to ban Red 40.

Summary, Tips from various sites:

• Make friends with your pharmacist.
• Ask your doctor for first-choice and second-choice prescriptions.
• Call the drug company yourself and recheck periodically.
• Prepare to argue with your insurance company. When generic medications are available, your insurance company will probably not approve the brand-name drug. Generic medications are not the same as the brand name formulation. If you need a brand-name medicine because no safe generic alternative is available, call your insurance company to learn what you’ll need to get approval for the more expensive form.
• Give an advance call before any outpatient medical tests, verifying the status of whatever they’re going to give you.
• If you require an unusual medicine for which no formulation is commercially available, ask your pharmacist to put you in touch with a pharmacy that does customized compounding.

Every life is temporary. Each life must be lived as meaningful and productive as the individual soul warrants. Every individual deserves the right to know and live as healthy as possible especially in our materially advanced culture.