Big Pharma's Guinea Pigs & Nazi Doctor-Type Ethics

Read any drug study involving a new diabetes drug and you'll notice that the subjects invariably start out with A1cs between 8 and 10%.

For anyone reading this who isn't diabetic, the A1c is a blood test that is used to assess long-term blood sugar control. Normal values are under 5%. The American Association of Clinical Endocrinologists' guidelines recommends that A1cs be kept under 6.5%, the leve at which dangerous complications become more likely.)

Drug companies trying to prove the efficacy of new drugs love the patient with a 10% A1c because those are the ones likely to show the most response to a drug. It's much better to be able to say, "Our drug dropped the average patient's A1c by a full 1%" than to say, "Our drug dropped the average a1c by .1%," which is what happens when you give a diabetes oral drug to a patient whose blood sugar is already under the level associated with diabetic retinopathy.

Even worse, when you look at the results of these drug tests, you also will see, just as invariably, that the drug only dropped the person with that 8-10% a1c by an average of 1%. So while the drop looks good, percentage wise, at the end of the year of study, the subjects were still running blood sugars well over the level where they are almost guaranteed to experience nerve damage, amputation, blindness and/or heart attack death.

And this is where the ethical problem arises that has me fuming.

If there were no way of lowering the typical diabetic's blood sugar below that damaging level, one could say, well, that is how it is. But this is far from the case. We have a drug that can lower the A1c to the safe levels in almost any diabetic--one that has been thoroughly tested and used in one form or another for almost 90 years: Insulin. But in these drug approval studies, NONE of the people with type 2 diabetes who are running those dangerous blood sugar levels are taking insulin.

So it seems to me that the patients in these drug studies who start out with that 8- 10%a1c should not be screwing around with experimental drugs. They should be put on carefully tailored insulin regimens until they have brought their A1cs down to the safe level below 6.5%. Then, once they are no longer walking time bombs, doctors can sign them up for new and experimental drugs that might lower their A1cs a tiny bit more.

You may hear doctors say that they can't get their Type 2 patients on insulin down to those levels, but if you probe further, you'll always find that the reason is that these same doctors are instructing their patients to eat a "healthy low fat diet" where each meal contains enough carbohydrates to overwhelm the generic insulin doses they've prescribed. Or you may find that they are only prescribing a basal insulin, like Lantus, which has no effect on the carbohydrates eaten at meals.

When doctors (or diabetes educators) take the time to learn how each individual's body responds to a set dose of insulin and design meal plans that work with sliding insulin doses, insulin, will bring blood sugar into the safe range of 6.5% or less. When doctors and nutritionists combine insulin used with moderate carb restriction (less than 25 grams per meal, for example) insulin can often bring blood sugar into the NORMAL range.

So if doctors were being ethical, i.e. working in the best interests of the patients, no study of any new and possibly ineffective drug should ever start with a population of diabetics whose blood sugar is at a level that even the ultra-conservative American Diabetes Association agrees causes severe complications. And those with responsibility for managing health care should make it clear that drug company operatives who draft patients into drug studies where their blood sugar from start to finish is allowed to remain in the danger zone are operating in an ethical zone only one step removed from Nazi doctors.

As Hippocrates said, "First Do No Harm!"