Thursday, November 14, 2019

W.H.O. and Generic Insulin

The World Health Organization (W.H.O) announced on Wednesday, right before World Diabetes Day on November 14, that it will be testing and certifying generic insulin in an effort to encourage companies to produce it. Patients in many developing countries simply can't afford the cost of current brand-name insulins, which can cost 20% or more of the patient's annual income. Many die as a result.

The idea is that if the insulins are tested and certified, patients would not be afraid to use them, and more pharmaceutical companies would produce them.

In theory, generic drugs are just as good as brand-name drugs. They are tested to make sure they contain the same amount of the active ingredient. However, the buffers and other inactive ingredients don't have to be the same. So a brand-name drug might dissolve at a uniform rate whereas the generic might dissolve faster, more slowly, or erratically.

Dr. Richard Berstein, author of The Diabetes Solution and an expert on low-carbohydrate diets, always says that Glucophage ($10 to $50 a month retail for 1000 mg a day) works better than generic metformin (free to about $5 a month). So I decided to try it. With my Plan D drug plan, it cost me $25 a month; the generic was about $2. The Glucophage did give me slightly lower blood glucose levels, but I didn't think the difference was worth more than $20 a month.

I once visually compared some generic drug, I think omprazole, that came in a capsule with the brand-name drug. The brand name consisted of tiny spheres, all the same size. The generic came in random shapes of different sizes. They were obviously saving money with cheaper equipment. Would this difference have made any difference in the release of the drug? I don't know. But the FDA doesn't test this, only that the drug contains the same amount of the active ingredient.

People sometimes find that a tablet has passed through them undissolved.

I know someone who found that some drug worked well until her insurance company made her switch to a generic, and then it didn't work. A sample size of one doesn't mean much, but it could be the same for others. If a generic drug doesn't work for you, sometimes your doctor can specify the brand name, and depending on your insurance, it may be covered.

I think it's clear that brand-name drugs are usually better than the generics. The question is how much better, and whether they're worth the higher price.

If you were living in a developing country and couldn't afford insulin, you would die. So in cases like this, generic insulin would definitely be better than nothing. During World War II, Eva Saxl, who had type 1 diabetes, was trapped in Shanghai, where no insulin was available. But her husband Victor learned to make insulin from slaughterhouse pancreases, and her life was saved. Any generic insulin certified by the W.H.O. would certainly be better than what Saxl was able to make under nonsterile conditions.

Eventually, the W.H.O.-approved insulin should be available in the United States, and the competition with Big Pharma should bring insulin prices down. The current prices are obscene, and the companies that charge them have no soul.

In the meantime, if you can't afford insulin, you shouldn't ration your supply. Walmart sells older insulins for about $25 a vial. They're not as good as newer insulins because they're peaky and unpredictable, but they work. I used NPH for a few months. It peaked at noon, and I often went low then, but I looked out for lows and coped with a little regular ice cream, followed by lunch, not something I'd recommend to anyone else, but it sure tasted good.

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