Ever wonder what's in a bottle of insulin? Don't believe the hype. Trusting individuals with insulin-dependent diabetes would bet their bottom-dollar it's insulin, right? In fact, what lurks beneath the designer label of patented formulas is a ruse of hypoglycemic agents commingled with preservatives, hazardous materials and fillers. Ready or not - here's the truth behind what's in a bottle of short-acting insulin analogues...

With the insight and assistance of a good friend, I was privy to the analysis of insulin analogues like Humalog, Apidra, and NovoLog. Big Pharmaceutical companies have been trumpeting the extraordinary glucose suppression of insulin analogues but at what cost?

What is an insulin analogue anyway? It sure ain't your father's insulin! An insulin analog is an altered form of insulin, different from the insulin secreted by the human pancreas. This means is does lower blood glucose, but without any of the inherent safety designs Mother Nature intended to prevent complications of diabetes (i.e., C-peptide).

Through genetic engineering of the underlying DNA, the amino acid sequence of insulin can be changed to alter its ADME (absorption, distribution, metabolism, and excretion) characteristics. Anybody feel like a science experiment yet?

Lest we not forget - genetic engineering costs big money. As the old saying goes time is money, so far be it from our trusting engineers to let a vial go to waste. Let me introduce you to a couple of star players in insulin that you must take into consideration with great caution: m-Cresol and methyl p-hydroxybenzoate.

Meta Cresol has been used for decades in insulin preparations, however the levels of m-Cresol have been silently creeping up, along with: costs, complications and better hemoglobin A1c levels. Wasn't the promise of rDNA insulin more affordable insulin? Didn't the insulin manufacturers promise if we control our blood glucose we would deter the onset of complications? Well, it looks like the majority has kept up with their end of the bargain. What's the holdup with the reduction in price and complications? I wonder if the preservatives are the fly in the proverbial ointment.

These insulin preservatives tend to shy away from the spotlight (even though they account for nearly as much as the insuliln analogue per milliliter. Insulins of yesteryear didn't have nearly as much m-Cresol as our beloved insulin analogues.

Each milliliter of Eli Lilly (NYSE: LLY) Humalog injection contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg m-Cresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

With how many of the above mentioned ingredients are you familiar? Moving on…

NovoLog, Novo Nordisk A/S (NYSE: NVO) is a sterile, aqueous, clear, and colorless solution, that contains insulin aspart (B28 asp regular human insulin analog) 100 Units/mL, glycerin 16 mg/mL, phenol 1.50 mg/mL, m-Cresol 1.72 mg/mL, zinc 19.6 µg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, and sodium chloride 0.58 mg/mL. NovoLog has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

APIDRA, made by Sanofi-Aventis (NYSE: SNY) is a sterile, aqueous, clear, and colorless solution. Each milliliter of APIDRA (insulin glulisine [rDNA origin] injection) contains 100 IU (3.49 mg) insulin glulisine, 3.15 mg m-Cresol, 6 mg tromethamine, 5 mg sodium chloride, 0.01 mg polysorbate 20, and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.

Of all the insulins I've used throughout my life - APIDRA was the ONE that broke the camel's back. Could it be the overabundance of meta cresol? Or perhaps does the dubious distinction belong in the Daltons of another foreign matter? You tell me.

Side effects of tromethamine include: renal failure. STOP. What's the point of insulin that comes a la carte` complications you are trying to avoid? Okay GO. Hyperkalemia - which is high potassium levels that could lead to heart failure. Still loving short-acting insulin analogues?  "Electrolyte disturbances" -- just a nice way of saying chronic deydration, and hypoglycemia.

Just for kicks, we should all have a gander at the HAZMAT on m-cresol. Are the risks of such preservatives worth the benefits?

Potential Acute Health Effects of Meta Cresol: Very hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Hazardous incase of skin contact (corrosive, permeator), of eye contact (corrosive). Slightly hazardous in case of skin contact (sensitizer). Liquid or spray mist may produce tissue damage particularly on mucous membranes of eyes, mouth and respiratory tract. Skin contact may produce burns. Inhalation of the spray mist may produce severe irritation of respiratory tract, characterized by coughing, choking, or shortness of breath. Severe over-exposure can result in death. Inflammation of the eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or, occasionally, blistering.

Potential Chronic Health Effects of Meta Cresol:

The substance may be toxic to kidneys, lungs, liver, skin, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage. Repeated or prolonged contact with spray mist may produce chronic eye irritation and severe skin irritation. Repeated or prolonged exposure to spray mist may produce respiratory tract irritation leading to frequent attacks of bronchial infection. Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in one or many human organs.

Chronic Effects on Humans of Meta Cresol: CARCINOGENIC EFFECTS: Classified POSSIBLE by IRIS. May cause damage to the following organs: kidneys, lungs, liver, skin, central nervous system (CNS).

So, in effect, the fast-acting insulin analogues chronically damage the Central Nervous System (CNS). It's NO WONDER long-term diabetes impairs the peripheral nervous system (PNS)! The CNS and the PNS work hand-in-hand (no pun intended). The central nervous system (CNS) represents the largest part of the nervous system, including the brain and the spinal cord. Together with the peripheral nervous system, it has a fundamental role in the control of behavior.

To summarize this blog in one question, I must ask: if you had a choice of a carcinogenic insulin with overabundant m-Cresol (for speed) or natural insulin (for safety)….isn't the choice obvious? Too bad the choice is no longer available.

• Wikipedia defines insulin analogues
• Preservatives in insulin and insulin analogues
• Side effects of tromethamine
• Tromethamine causes Hyperkalemia
• HAZMAT information on m-Cresol

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