Tim Lundeen, whose fish oil/arithmetic results impressed me, recently tried taking benfotiamine (a fat-soluble version of thiamine) to reduce damage caused by high blood sugar. Things did not go as he expected:
I bought 100mg capsules from Life Extension Foundation, and starting taking 1 per day in the morning with breakfast. Over the course of 3-4 weeks, the two small dead spots on the bottoms of my big toes started to feel normal, and I didn’t notice them anymore when I went walking. My energy and general mood were good, and my fasting blood sugar readings were basically unchanged, staying in the 85-95 range. Scores on my daily math speed test were good, possibly slightly better than before.
Unfortunately, I started to gain weight, gaining about 10 pounds over the 10 weeks I took benfotiamine, without any other major changes to my regimen.
Weight gain was not a known side effect. For example, a 2005 study in which 20 patients received the drug for three weeks reported: “No side effects attributable to benfotiamine were observed.” This is on a web page that is trying to sell benfotiamine but there’s nothing unusual about the situation. Studies of drug efficacy are almost always done by drug companies that want to sell the tested drug. What is the term for such a side-effects reporting system? The fox guarding the hen house, perhaps?
It isn’t easy to measure side effects in conventional studies of treatment vs placebo. If you measure the rates of 100 possible side effects, and use a 5% level of significance, one or two true positives will go unnoticed against a background of five or so false positives. So a drug company can paradoxically assure that they will find nothing by casting a very wide net. And there is a larger and more subtle problem that statistics such as the mean do not work well for detecting a large change among a small fraction of the sample. If soft drinks cause 2% of children to become hyperactive and leave the other 98% unchanged, looking at mean hyperactivity scores is a poor way to detect this. A good way to detect such changes is to make many measurements per child. Many did-a-drug-harm-my-chlld? cases come down to parents versus experts. The experts are armed with a a study showing no damage. But this study will inevitably have the weaknesses I’ve just mentioned — especially, use of means and few measurements per subject. The parents, on the other hand, will have used, informally, the more sensitive measurement method.
For these reasons, I suspect drug side effects are woefully underreported. Here is the story of a child with a neurodegenerative disease that might have been caused by “the Gardasil vaccine (or perhaps some other vaccine with key similarities, such as an aluminum adjuvant).” Her parents are trying to find other children with similar symptoms.