This is a guest artile by Silvio Aladjem MD.

©The modern pharmacotherapy is a medical achievement nothing short of extraordinary. Sort of “you name it and we have it”. In this country, the Pharma industry is overseen by the FDA who must approve any drug before it reaches the market. Thank God for that. Can you imagine how many “Snakes Oils” would flood the market if it weren’t for the FDA?

The approval process is long, sometime years, at a staggering cost for the industry. The laboratory steps, the experimental phase and eventually the clinical trials, are necessary steps a new drug must go through before it reaches the public.

It is estimated that only a fraction of the new drugs that are in the making, are eventually approved and allowed to be marketed.

All this comes about because of a new study released recently (https://medlineplus.gov/news/fullstory_166344.html ), confirming prior observations which linked certain new drugs for the management of Type 2 Diabetes with some serious and life-threatening complications, known as Ketoacidosis.

How is that possible? Certainly, the FDA approved the drugs and considered them to be safe. I can explain the apparent inconsistency. All drugs have unintended consequences, known as side effects and have certain contraindications. For example, pregnant women should not use it. The clinical trials which proved the drug to be “safe” and appropriate for the diseases they were intended to treat, usually consist of a few thousand patients at most.

Realistically, one can’t expect that all possible complications of a new drug will appear when used on a limited number of patients. Once on the market, that number explodes and hundreds of thousands, if not millions, use it. Untoward effects that may not have been apparent prior to approval, raise their ugly heads now, by virtue of numbers of people using it. It’s not unlike the lottery. The odds are against you having any problems, but if they happen, it’s all yours. The 1% risk, which seemed reasonable to take when you see it on paper or you are told by your physician, now becomes 100%.

This is a game you play whether you take an aspirin or a newly released drug.

In our society, the question we need to ask is: did we need a new drug, when other current drugs, intended for the same disease, have proven real safe after decades of use.

That’s when market forces come in, which when combined with patient preferences and/or desire to take the latest drug which surely must be better than those other, explain the flow, or deluge, of similar drugs on the market. Just look at the shelves of drugs for “arthritis”.

Add to that the industry’s push to have the same drug, usually in a lower dose, sold over the counter and the direct advertising to the public, and we have a setup for accidents waiting to happen. I don’t blame the consumers. Their lack of information always astounded me. I had patients that were taken drugs the name of which they did not know, not being able to mention a single potential side effect, and were taking the drug because “the doctor prescribed it” or a friend recommended. Add to that the flood of advertising to the public, where the majority of “patients” are young, vigorous and looking healthy, playing with kids, with friends, or dancing, while the add is careful in telling them how good the drug is, followed by a list of potential complications, including “death” in which case, you are told, you should stop taking the drug and consult a doctor.

Take, in this case, Type 2 diabetes where losing weight and changing the individual’s life style and eating habits, sometime suffice.

The problem arises when that is not enough and current available drugs are not controlling the blood sugar. That is where the new SGLT2 inhibitors come into play. They have been designed to control the blood sugar by forcing the kidney to eliminate it in the urine, which normally does not occur. In fact, finding sugar in the urine is grossly abnormal. These new drugs are treating one condition, Type 2 diabetes, by altering the normal function of the kidney!

The alternative for the patient is to start a regimen of insulin. Patients don’t like injections, and I understand that. We have been using insulin for over 100 years. The most feared side effect of insulin is low blood sugar (hypoglycemia). When used correctly, this should not happen or be manageable without too much difficulty. I have had Type 2 diabetes for almost 20 years, and I ask myself: would I risk an unexpected ketoacidosis because I prefer a pill to a shot? No way.

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SILVIO ALADJEM MD, an obstetrician/gynecologist and Maternal Fetal Medicine (high risk obstetrics) specialist, is Professor Emeritus in obstetrics and gynecology at Michigan State University, College of Human Medicine, in Lansing, MI. He is the author of “10,000 babies: my life in the delivery room” now available on Amazon, Barnes and Noble and other book stores. Dr. Aladjem published extensively in Scientific Medical Journals and wrote several textbooks in the specialty. He can be reached at: dr.aladjem@gmail.com

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