Seth’s blog

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.

The Food and Drug Administration has settled a lawsuit related to mercury in dental fillings. As part of the settlement, it will acknowledge that these fillings may harm some people. This is from an email by someone behind the lawsuit:

To change FDA policy, we tried petitions, Congressional hearings, state fact sheet laws, Scientific Advisory Committee hearings, and letters galore — to no avail. So in the great American tradition, we sued. The case came to a head this spring. On April 22, working with Johann Wehrle and Gwen Smith, I filed a motion for an injunction before Judge Ellen Huvelle. Three sets of briefs later, the government and I presented our oral arguments on May 16. In a crucial ruling, Judge Huvelle ruled that our 11 plaintiffs — the diverse group
listed below — have standing. She said FDA should classify, and invited the two sides to mediate. On May 30, before Magistrate Judge John Facciola, Bob Reeves (who flew in from Lexington KY) and I hammered out an agreement with FDA officials and lawyers.

The impact of the re-writing of its position on amalgam can hardly be understated. [A curious mistake: the writer means overstated.] FDAs website will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgams risk to
children, young women, and the immuno-sensitive persons in its website, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.

Mercury fillings were once very common and are still common. Unfortunate that it took a lawsuit to get the FDA to change. Judges have little or no relevant experience understanding scientific papers. Scientific advisory panels have much more relevant experience. However, they suffer from a “purity” bias – they are evidence snobs.

Thanks to Dev Rana.

After reading an excellent article about Craig Newmark by Philip Weiss in New York magazine, I turned to a New York article about controversy over how to deal with autism. (New York, you see, is more humble and thus more interesting than The New Yorker.) Its author, Andrew Solomon, who wrote The Noonday Demon, once wrote about the deaf rights movement. The neurodiversity movement is similar. What I found most revealing about Solomon’s article is the level of animosity he uncovered.

Researching this article, I spent a lot of time being talked at by people on both sides, one more doctrinaire than the next. Not since my early days reporting from the Soviet Union had I found myself so bullied about what I should and shouldn’t be mentioning.

It’s a kind of debate that didn’t happen until recently: on one side are parents who want to help their kids; on the other side are people who want more acceptance for autistic behavior. On the face of it they should be allies but in reality they are enemies. It reminds me of my complaint about how graduate students are trained (or rather not trained): they never learn to praise, to see what’s good about this or that study, so their natural inclination to be negative does a lot of damage.